Medical Product Outsourcing

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Owens & Minor Aborts Merger Deal with Rotech

2 days ago | mpo-mag.com | Sam Brusco

Owens & Minor and Rotech gave mutually agreed to terminate their previously announced acquisition. Per the merger agreement, Owens & Minor paid $80 million to Rotech and will also redeem the $1 billion of notes issued in April 2025, which include a mandatory redemption provision. The company will also terminate the incremental term loan commitments and senior unsecured bridge loan commitments provided by its lenders.
FDA Clears 1st AI Platform to Predict Breast Cancer

3 days ago | mpo-mag.com | Sam Brusco

Clairity has received U.S. Food and Drug Administration (FDA) de novo authorization for Clairity Breast, an image-based prognostic platform that leverages artificial intelligence (AI) to predict five-year breast cancer risk from a routine screening mammogram. The tool analyzes subtle imaging features on screening mammograms that correlate with future risk of breast cancer.
Fresenius Medical Care Releases 5008X CAREsystem

4 days ago | mpo-mag.com | Sam Brusco

Fresenius Medical Care (FME) recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for the updated version of its new, hemodiafiltration-capable 5008X CAREsystem.
Cardinal Health Rolls Out Kendall DL Vital Signs Monitor

4 days ago | mpo-mag.com | Sam Brusco

Cardinal Health has launched Kendall DL, a new multi-parameter, single-patient use monitoring cable and lead wire system for continuous cardiac activity, blood oxygen level, and temperature monitoring with one point of connection. The Kendall DL Multi system was designed to travel with the patient from admission to discharge.
FDA OKs Mindset Medical's Contactless Respiratory Rate Measurement

4 days ago | mpo-mag.com | Sam Brusco

Digital health company Mindset Medical has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its latest contactless vital sign monitoring device, the Informed Vital Core (IVC) app. The IVC app is a software-only medical device that measures respiratory rate using smartphones, tablets, or laptop cameras. This is Mindset Medical’s second FDA nod in under a year—its pulse rate measurement device was cleared in November 2024.
NanoVibronix Has a Leadership Transition

4 days ago | mpo-mag.com | Sam Brusco

NanoVibronix revealed that Brian Murphy has retired as its CEO, effective immediately. The board appointed Doron Besser, CEO of the company’s subsidiary ENvue Medical, as its new CEO—also effective immediately. Murphy will stay on the company’s board as a director, continuing his service to support governance continuity at the board level.
To Have and to Mold: A Discussion on Medical Molding

5 days ago | mpo-mag.com | Sam Brusco

Medical injection molding fabricates plastic medical devices and components by melting plastic resin pellets and injecting the molten material into a mold to create specific shapes. The method allows control over size and shape, adhering to strict quality and regulatory standards. It’s a common method to form plastic parts with tight tolerances, capable of producing U.S. Food and Drug Administration (FDA)-approved devices that are reliable and durable.
How AI and Agentic AI Reduce Medical Device Malfunctions

5 days ago | mpo-mag.com | Sam Brusco

While smooth operations are a universally shared business goal, device functionality is a life-or-death matter when it comes to sensitive industries like healthcare. The U.S. Food and Drug Administration (FDA) reports that medical device malfunctions caused nearly 83,000 deaths¹ over a recent 10-year period. Maintenance is increasingly relevant as tech complexity and growing demand put continuous pressure on the healthcare industry.
Reflow Medical Earns De Novo OK for Spur Peripheral Retrievable Stent

5 days ago | mpo-mag.com | Sam Brusco

Reflow Medical has received De Novo clearance from the U.S. Food and Drug Administration (FDA) for its Spur peripheral retrievable stent system. Spur is used to treat de novo or restenotic lesions after predilatation in patients with infrapopliteal arterial disease. According to the company, it’s the first, only retrievable stent with an integrated dilatation balloon catheter on an over-the-wire system.
BiVACOR's Total Artificial Heart Wins FDA Breakthrough Nod

5 days ago | mpo-mag.com | Sam Brusco

BiVACOR has received U.S. Food and Drug Administration (FDA) breakthrough device designation for its world-first titanium Total Artificial Heart (TAH). The designation supports the BiVACOR TAH as a bridge-to-transplant (BTT) for adult patients with severe biventricular or univentricular heart failure where current treatments (including LVADs) aren’t viable.