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Top 40 Medical Device Companies mddionline.com

Details: 41 rows · There has been a lot of change on medtech's leaderboard over the past 12 months. For a more recent ranking of medical device companies, download the free Medtech Insight’s MTI 100, the latest ranking of global medtech companies, prepared by Medtech Insight (a sister publication of MD+DI).

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Mobile App Tracks Patient Status Through Discharge

Details: 4 hours ago · The company noted that the platform uses privacy-by-design principles and is regulatorily-compliant in the United Kingdom, Europe, and the United States. The cloud-based application is fully encrypted and protected, Careful said. It is also fully interoperable using industry standard messaging – so that it can integrate with healthcare

› Verified 2 days ago

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Move over Medtech, Pharma Is Embracing AI, Too!

Details: 19 hours ago · The Rahway, NJ-based company said it welcomes applications for 12 spots for the first MDSS cohort. Merck said startups developing AI and ML applications will be prioritized. The MDSS is a collaboration between Merck and the New Jersey Innovation Institute (NJII), a New Jersey Institute of Technology corporation, with investments from the Merck

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Is Acutus Back on Solid Ground with New FDA Nod

Details: 2 days ago · Omar Ford | Jun 27, 2022. Acutus Medical is putti 2021 behind with a new nod from FDA. The Carlsbad, CA-based company has won clearance for the commercial launch of its AcQCross Line Extension, a transseptal access system. The newly cleared device is for use with the TruSeal and FXD delivery system for Boston Scientific’s Watchman LAAC device.

› Verified 8 days ago

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Most Innovative Medtech Companies in 2022

Details: Demonstrating the significant impact of medtech, Fast Company has recognized 10 innovative medical device companies in their own list this year, instead of including medtech in the health category of its Most Innovative Companies list. Be sure to check out Fast Company for its ranking.. Here we cover the 10 medical device companies that Fast Company is honoring …

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Personalized Surgery: A New Future for Orthopedic ORs

Details: 1 day ago · Introducing personalized surgery. The general public was introduced to the concept of “personalized medicine” in 1999, when a Wall Street Journal article discussed how drugs could be targeted for individual patients based on each person’s unique genetic profile. At that time, orthopedic surgeons were completing an average of 100 to 150

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Heart Disease AI Software Maker Scores $27M

Details: AI The company’s noninvasive software was developed to create quantifiable information on the tissue being evaluated in the heart using algorithms and machine learning. Specifically, the technology is designed to identify changes due to plaque buildup, necrotic core that has a high lipid concentration (Lipid Rich Necrotic Core), and other

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Medtronic to Spin Renal Business into New Company

Details: The new company will develop kidney care products and solutions, including future home-based products, to make different dialysis treatments more accessible to patients. "This is an exciting moment that will shape the future of kidney care," said Ven Manda, president of Medtronic's renal care solutions business, who will serve as CEO of the new

› Verified 6 days ago

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Which Medical Device Company Is the Best to Work For

Details: The Minnesota-based company has had one of the best-performing stocks of 2015, and the fact that St. Jude is promoting from within to replace the outgoing CEO suggests the board feels the company is on the right track. The company's Glassdoor ranking has improved from 2.9 last year to 3.1 today. Abbott acquired St. Jude Medial in January 2017.

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This Company Is Reinventing the Heart Valve

Details: The company is using a robotic manufacturing pod platform designed to efficiently manufacture the heart valve anywhere in the world without a large skilled workforce or manufacturing facility. "We can reliably produce these things of the highest quality the exact same way from the day the robot turns on to the day the robot turns off," Charhut

› Verified 3 days ago

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Boston Scientific Takes Majority Stake in M.I. Tech

Details: Amanda Pedersen | Jun 15, 2022. After an acquisitive 2021 , Boston Scientific has been relatively quiet this year on the M&A front. However, the Marlborough, MA-based company just announced an agreement to buy a majority stake (about 64%) in M.I. Tech. Based in Korea, M.I. Tech makes medical devices for endoscopic and urologic procedures.

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Building a Better Medical Device Supply Chain mddionline.com

Details: Sanjay Gupta, VP Integrated Supply Chain at Imbed Biosciences, says it's time to look inward to build a more robust medical device supply chain. In 2021, the size of the global medical devices market was pegged at around $450 billion USD (Precedence Research, Fortune Business Insights) and is forecasted to grow to $700 billion within the next

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Are the Salad Days of COVID-19 Testing Over for Diagnostic Firms

Details: 1 day ago · Cue Health grew into a diagnostic powerhouse because of COVID-19 testing. The San Diego, CA-based company was one of the few firms in the space to go public through a traditional IPO during the pandemic while others went through the Special Purpose Acquisition Corporation merger route.. But Cue’s success has been hampered because of the decline in …

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Some of BD’s Intraosseous Devices Face a Recall

Details: Becton Dickinson & Co. has announced a voluntary recall of its Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits and Intraosseous Powered Drivers. The Franklin Lakes, NJ-based company said affected needle kits should be destroyed in compliance with the health care institution's process for disposal. The use of affected intraosseous

› Verified 7 days ago

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Endologix Shares Encouraging 12-Month Data from DETOUR 2

Details: 2 days ago · Endologix, a private company, that provides interventional treatments for vascular disease, announced the 12-month results from the DETOUR 2 clinical trial. DETOUR 2 was an IDE study, designed to evaluate safety and effectiveness of the Detour System for percutaneous bypass in the treatment of long-segment femoropopliteal disease.

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How to Evaluate Medical Device Technologies mddionline.com

Details: The company has been notably unsuccessful with products in other quadrants, however. Guidant shares Medtronic's attributes on the cardiac rhythm management side but has struggled at times to keep up with the rapid product cycles on the interventional side. Guidant's recent successes clearly indicate that it is recovering, and its rich pipeline

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Patent Spat Between AliveCor & Apple Becomes Intense

Details: 17 hours ago · The spat between the two began in December of 2020, when AliveCor filed a federal lawsuit regarding the patent infringement. In April of 2021 the company said it wanted to block the importation of all the Apple Watches in the U.S. and filed a patent infringement complaint with the International Trade Commission.

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Medical Device Manufacturers Hit Major Hurdles—Can Contract

Details: The company is also doubling its packaging capability and capacity through the acquisition of CPP in July of this year. Natech has added additional automation equipment, including collaborative robots for the production floor, along with testing equipment and new machinery, Turrell reports. “Our team now can fill and seal, sterile pack, and

› Verified 7 days ago

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Most Innovative Medtech Companies in 2022 mddionline.com

Details: Ambu introduced the first disposable airway endoscope in the United States in April 2010 and has been expanding its scope lineup ever since. “Flexible endoscopes raise specific problems because they are costly to purchase, reprocess, and repair; they are not always available when you need them; and their use risks exposing patients to infections,” then-CEO …

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Can Human Longevity Keep SPACs Alive in a Bumpy Economy

Details: The San Diego, CA-based company said earlier this week that it signed a non-binding letter of intent with Freedom Acquisition 1 Corporation for a proposed business combination. Under the terms of the SPAC, Human Longevity would become the parent company. The merger is valued at $1 billion, and the transaction signing is anticipated by …

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Effective Project Management for Medical Devices

Details: Effective project management policies and practices are vital for successful new medical device product introductions. Effective policies are also critical in order to appropriately address compliance with U.S. requirements specified in the quality system regulation and international requirements in standards such as ISO 13485 and ISO 9001:2000. 1–5 These …

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Steps to Equipment Qualification mddionline.com

Details: An official copy of the protocol is printed and the tester fills in results of the procedure for the test section performed. Equipment qualification is a necessary and critical step in ensuring that a product or service is provided accurately and consistently with requirements aligned with medical device manufacturing and testing.

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Beta Bionics Shines with iLet Bionic Pancreas Data

Details: Omar Ford | May 02, 2022. Fresh off raising $57 million in a series C round, Beta Bionics is giving investors another reason to be excited – strong data. The 2018 MDDI Readers’ Choice for Company of the Year, and Boston, MA-based company unveiled data that show the iLet Bionic Pancreas reduced HbA1c and Improved Time in Range vs Standard of

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The Narrowing Distribution Funnel: How to Get Your Medical …

Details: Provided the device company has the necessary manufacturing capacity to produce sufficient quantities, private labeling—especially for a large customer—can dramatically increase sales by taking advantage of the customer's marketing, advertising, and distribution resources. Obviously, private-label marketing carries risks.

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12 Key Questions for Selecting a Supplier mddionline.com

Details: Engineering, the group that knows the product best. Quality, the department that ensures that quality standards are achieved. Documentation, that makes sure the document systems used by the OEM and the supplier are compatible. Finance, the group that ensures any deal with the supplier is a sound financial move. 4.

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Dexcom’s CEO: FDA’s Nod for G7 Could Come Sometime After ADA

Details: Dexcom winning a nod from FDA for the G7 continuous glucose monitoring system is one of the biggest questions in Diabetes Tech. During a 1Q22 earnings call, the San Diego, CA-based company’s President, CEO, and chairman, Kevin Sawyer, shed more light on when one of medtech’s most anticipated devices could obtain a nod from FDA.

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Legal Liabilities of Medical Device Outsourcing mddionline.com

Details: Whether a company uses its own facilities or contracts, or outsources, with another firm to manufacture a device, the responsibility for compliance is the same for the company. This article briefly reviews the provisions of the FD&C Act that apply to manufacturer responsibility, the process of identifying and selecting a contract manufacturer

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Obtaining Coverage and Reimbursement from Commercial Payers

Details: Even more challenging is the path to reimbursement from commercial payers (i.e., private insurers). Each commercial payer follows its own set of rules. Coverage and payment policies vary from payer to payer, and sometimes from product to product, for medical benefits including devices. Manufacturers must approach each payer separately, and

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The Top 10 Cardio Device Companies: Highlights from TCT

Details: At TCT, the company was highlighting its Misago "spineless" self-expanding peripheral stent, which was launched this summer to the U.S. market. Its spine-free design reportedly optimises the stent's radial force applied to the peripheral artery. Cardio has helped the Japanese company have one of the best-performing medtech stocks of 2015. 9. W. L.

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The Medical Device Industry Needs Risk Management in the New …

Details: Michael Kolias | May 15, 2020. Amid the current COVID-19 pandemic, many medical device manufacturers and suppliers are moving at unprecedented speeds to develop and enact updated risk management policies and procedures. Much of what they are developing are plans to help manage manufacturing and supply-chain challenges in times of crisis.

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Live from MD&M East: Momentive Launches High-Tear-Strength LSR

Details: A new high-tear-strength liquid silicone rubber (LSR) is now available to medical device OEMs, Momentive Performance Materials announced today at MD&M East in New York City. Suited for such applications as sleep apnea masks, catheter components, and seals and stoppers for single-use syringes, the

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Tyco Healthcare to Become Covidien mddionline.com

Details: The new company will remain at Tyco Healthcare's Mansfield, MA, headquarters, where it employs 1300 people. Another 700 are employed at two other locations in the state. Covidien will continue to manufacture all of Tyco Healthcare's disposable, wound care, and medical instrumentation products across its Autosuture, Kendall, Mallinckrodt

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Medical Device Distribution in an International Market

Details: Distribution in foreign countries can pose special difficulties; unless manufacturers take steps to avoid these problems, profits will suffer. F oreign countries are a substantial part of the market for most U.S. medical device companies. In fact, public medical device companies conduct approximately 30­45% of their sales internationally.

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BMS Sells ConvaTec: Are More Private Equity Deals on the Way

Details: Earlier this month, Bristol-Myers Squibb Co. (New York City) announced its intention to sell its ConvaTec unit to private equity firms Nordic Capital (Stockholm, Sweden) and Avista Capital Holdings LP (New York City) for $4.1 billion. Based in Skillman, NJ, ConvaTec is a leading manufacturer of wound therapeutics and ostomy care products, and

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Why Monarch's New Clearance Is Big for J&J’s Surgical Robot

Details: Omar Ford | May 04, 2022. Ethicon, a Johnson & Johnson MedTech company, announced news that should bring back some much-needed attention to its robotic-assisted-system program. Through its Auris Health subsidiary, Ethicon said it won FDA clearance for the Monarch platform to be used in endourological procedures.

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Finding a Safe Harbor: Anti-Kickback Implications of Medical …

Details: This article reviews the application of the Anti-Kickback Statute to medical device consulting agreements. (Although the case law developed around the marketing practices of pharmaceutical companies and healthcare providers, it is equally applicable to device manufacturers.) Some of the common pitfalls of consulting agreements are discussed

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Funding a Medical Device Start-Up mddionline.com

Details: For years, medical technology has been a fertile area for new companies. Many of today's leading medical device companies began as start-ups founded by industry professionals who took a risk. Valuation of these companies rose to millions—and even billions, in some cases—as the firms grew over the years. Nellcor, Acuson, Ventritex

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J&J Medtech Execs Say Strategic Merit, Not Size, Matters in M&A

Details: J&J announced plans in November to split into two companies, with the medtech and pharmaceutical businesses becoming the "new Johnson & Johnson" and the consumer business becoming its own separate company. The split is expected to happen in 2023. Wolk said the new Johnson & Johnson portfolio will remain "well diversified" with 25 brands

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Top 10 Molecular Diagnostics Companies: a Closer Look

Details: The company's molecular test revenues are "bolstered by the continued dominance of its Ventana Medical histology business," points out Bruce Carlson, Kalorama's publisher. Second on the list is Qiagen, which transformed itself from a molecular sample-prep technology manufacturer to a very successful molecular test company. Nearly half of its

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