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September 2023 edition: The Medtech Big 100

5 keys to Mike Mahoney and Boston Scientific’s success

How does medtech CEO compensation stack up to the rank and file?

Digital health startups to watch as Big 100 firms race to build or buy tech

DeviceTalks West show preview: Find solutions to your most demanding medtech problems

A mixed year for the Medtech Big 100 — and an opportunity to show we care

The results are in from our annual Medtech Big 100 ranking of the largest medical device companies, and while total sales and R&D spending are up, it doesn’t feel right to celebrate.

That’s because our analysis shows a 5% decline in employment across the industry. This is no surprise to anyone who is active on LinkedIn, given this year’s headlines about layoffs and posts from friends and co-workers seeking new opportunities.

It’s not the first time that’s happened. Last year’s analysis captured job cuts due to the COVID-19 pandemic that delayed procedures, snapped supply c…

LivaNova wins FDA clearance, CE mark for Essenz in-line blood monitor

The Essenz in-line blood monitor. [Image courtesy of LivaNova]LivaNova (Nasdaq: LIVN) + announced today that it received FDA 510(k) clearance and CE mark for its Essenz in-line blood monitor.

Essenz ILBM provides accurate and continuous measurement of essential blood parameters throughout cardiopulmonary bypass (CPB) procedures. It integrates into the next-generation Essenz perfusion system. Essenz enables perfusionists to access and manage reliable blood parameters directly from the system’s cockpit. It eliminates the need for additional monitors or holders.

London-based LivaNova says that existing blood-gas analyzers only reflect the patient’s clinical condition at the exact moment a sample is drawn. This sample can quickly change and the analysis becomes irrelevant. Essenz ILBM provides in-line, continuous monitoring for the duration of a procedure. LivaNova said this allows for the delivery of a patient-t…

Philips prices $546.2M offering to repay existing debt

Philips (NYSE: PHG) + announced today that it priced a fixed-rate notes offering worth $546.2 million (€500 million).

Amsterdam-based Philips priced the notes (due 2031) under its European medium-term note (EMTN) program. The issue of the notes has a debt-neutral effect.

Philips said in a news release that it intends to use the net proceeds to repay debt. This debt comes from the funds utilized and outstanding under the credit facility entered into in the fourth quarter of 2022. Other uses of proceeds include general company purposes.

The company set the issue price for the notes at 99.741% with a coupon of 4.25%, resulting in a 4.289% yield. Philips said the offering was two times oversubscribed. It scheduled the settlement and issue of the notes for Sept. 8. The company also applied for the listing of the notes on the Official List of the Luxembourg Stock Exchange and to be traded on the regulated market of th…

Ginkgo Bioworks and Google Cloud forge five-year AI and biology partnership

Ginkgo Bioworks’ pioneering capabilities in harnessing vast biological data. [Image courtesy of Ginkgo Bioworks]

Founded in 2008, Ginkgo Bioworks’ stock jumped almost 25% on August 29, hitting $2.22, after unveiling a five-year partnership with Google Cloud. The partnership centers around the development of novel AI tools for biology and biosecurity. In particular, Ginkgo hopes to further its mission to make biology easier to engineer in the AI era.

Opting to make Google Cloud its primary cloud services provider, Ginkgo plans to develop new large language models for biological engineering applications based on Google’s Vertex AI platform. Debuting in 2021 as a framework for streamlining the machine learning lifecycle, Vertex AI has since evolved to incorporate more generative AI capabilities.

Further solidifying the partnership, Google Cloud will also help fund Ginkgo’s development of foundation mod…

Aion wins FDA clearance for skin-wearable body temperature monitoring device

The iTempShield system received FDA clearance. [Image from Aion Biosystems]Aion Biosystems announced today that it received FDA 510(k) clearance for its iTempShield device and software system.

iTempShield received approval for use in adults and children five years of age and older. It covers use in hospitals, outpatient facilities, remote patient monitoring environments and over-the-counter sales.

Boston-based Aion designed the quarter-sized, skin-wearable monitoring device with support from cloud-based software and proprietary algorithms. It enables the continuous measurement of body temperature for a variety of clinical applications. That includes oncology sepsis monitoring, post-surgical infection detection, long-term monitoring and consumer home health.

The company says iTempShield’s accuracy comes in four times higher than an oral thermometer.

More about the Aion Biosystems iTempShield device

iTempShield adheres to the surface of the skin …

AdvaMed outlines new Medicare AI and software strategy

AdvaMed, the Medtech Association and CapView Strategies today released a white paper on the ethical incorporation of AI and software in Medicare.

The report — Medicare Policy at the Crossroads – Addressing Artificial Intelligence and Software — details the ways to help advance this incorporation into Medicare coverage and payment policies. It outlines a strategy for Medicare AI and software and makes targeted recommendations to improve Medicare’s payment systems, accounting for these technologies.

“CMS has taken significant, but only incremental, steps to bring the benefits of AI and software solutions that are themselves medical devices or that improve medical devices used in care for Medicare beneficiaries” said Scott Whitaker, president and CEO of AdvaMed. “The agency must now show leadership in pursuing a strategy to address access, equity and ethical issues for AI/software innovations in Medicare and across the health care system.”

The AdvaMed…

Emergent BioSolutions launches over-the-counter Narcan nasal spray

Narcan. [Image from Emergent BioSolutions]Emergent BioSolutions (NSYE:EBS) announced today that it plans to put its over-the-counter Narcan nasal spray on U.S. shelves next month.

FDA approved the over-the-counter Narcan spray in May. Approval enabled direct-to-consumer sales in places like drug stores, convenience stores and more. The FDA nod came about six weeks after an agency committee voted unanimously in favor of OTC use. It marked the first approval for a naloxone product for use without a prescription.

The naloxone HCl nasal spray (4 mg) will become available on shelves nationwide and online beginning in September.

Get the full story at our sister site, Drug Delivery Business News.

Myomo closes $4.4M public offering

[Image courtesy of Myomo]Myomo (NYSE:MYO) announced today that it closed its previously announced offering worth proceeds of approximately $4.4 million.

The Boston-based wearable medical robotics maker priced its “reasonable best efforts” public offering last week. It included more than 7.3 million shares of common stock priced at 60¢ per share. Members of management, affiliated investors and certain high-quality, healthcare-focused investors participated in the offering. A.G.P./Alliance Global Partners acted as the sole placement agent for the offering.

Myomo plans to use proceeds for general corporate purposes, according to a news release. That may include working capital and capital expenditures, R&D expenses and sales and marketing activities. Funds may also go toward company growth, contingent on the implementation of a new Medicare rule.

Earlier this year, the Centers for Medicare and Medicaid Services (CMS) announced a new proposed ru…

Cardinal Health launches next-gen neonatal feeding device

Cardinal Health (NYSE: CAH) + announced today that it launched its next-generation NTrainer 2.0 device for neonatal feeding.

Dublin, Ohio-based Cardinal Health designed the NTrainer 2.0 to help premature and newborn infants develop oral coordination skills. These skills — important for a speedy transition to independent feeding — helps to reduce NICU length of stay.

Through real-time assessment technology, NTrainer 2.0 offers clinicians with objective data to track an infant’s progress. It provides parents with confidence on the progress and the potential to thrive after discharge, according to a news release.

Cardinal Health says the system provides key pre-feeding skills in newborns and preterm infants known as non-nutritive suck (NNS). Its design supports proper suck-swallow-breathe coordination in premature infants to reduce time to achieve full oral feeding.

NNS is critical for the safe transit…

Fast Five: Biotronik implants first next-gen pacemaker, PolyVascular and CobiCure partner for pediatric heart valves

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, August 30, 2023.

Fast Five by MassDevice · Biotronik implants next-gen pacemaker, PolyVascular and CobiCure partner for pediatric heart valves

Implantable continuous glucose maker Glucotrack announced it has a new VP of marketing. Fast Five hosts Sean Whooley and Danielle Kirsh talk about the new VP and their career history that supports the appointment.

Haemonetics is expanding its global presence by launching its vascular closure device in Europe. Find out which device is going global, how it works and what’s next for Haemonetics.

The FDA granted 510(k) clearance to ICU Medical’s infusion pump and software. Whooley explains what the they do and some of the features that make patient monitoring seamless.

Pediatric devices is an underserved market…

Hoffer Plastics names three co-CEOs

Hoffer Plastics co-CEOs (from left) Gretchen Hoffer Farb, Alex Hoffer and Charlotte Hoffer Canning [Photo courtesy of Hoffer Plastics]

Hoffer Plastics recently named Gretchen Hoffer Farb, Charlotte Hoffer Canning and Alex Hoffer as co-CEOs.

The three siblings are the third generation of family leaders for the South Elgin, Illinois-based medtech supplier. Their grandparents, Bob and Helen Hoffer, founded the business in 1953.

“Gretchen, Charlotte and Alex each bring distinct passions, perspectives and expertise to the table,” their father, former CEO William Hoffer, said in a news release. “But they have one crucial thing in common, and that’s a commitment to carrying on the Hoffer family legacy,”

Bob Hoffer served as CEO for more than 40 years. William Hoffer, who served as the company’s second CEO, will remain board chair.

The three siblings took on C-level responsi…

Radiaction raises $12.6M for radiation protection tech

Radiaction Medical announced today that it raised $12.6 million in Series C2 funding and elected Christopher Barys to its board.

U.S. private equity fund InnovaHealth Partners led the Tel Aviv, Israel-based company’s round. Additional unnamed co-investors participated.

Radiaction develops a novel system designed to proactively block radiation from the source. It provides comprehensive, head-to-toe radiation protection for the entire interventional team. Meanwhile, it enables unencumbered patient care, access and service, according to a news release.

Backed by extensive lab testing and real-world validation, the company looks to expand its footprint in the U.S. It’s adding new sites to its user base, providing key support staff to ensure the success of each system installation. The company also looks to develop additional features and grow its clinical publication pipeline to support the technology’s performance.

“This current fin…