Hurricane Maria poses threat to med device hub in Puerto Rico

Hurricane Maria is posing a threat to medical device and pharmaceutical manufacturing plants in Puerto Rico, according to a new Bloomberg report. The island is home to facilities for Johnson & Johnson (NYSE:JNJ), Pfizer (NYSE:PFE), Amgen (NSDQ:AMGN), Merck, Medtronic (NYSE:MDT) , Abbott (NYSE:ABT), Stryker (NYSE:SYK) and dozens of others, according to the report. Most of the companies created facilities in Puerto Rico due to tax incentives, Bloomberg reports.

Abiomed buys Danvers, Mass. HQ for $17m

Abiomed (NSDQ:ABMD) said this week it inked a deal to purchase its existing corporate headquarters in Danvers, Mass. for $16.5 million. The company said that it opted to buy the facilities, which includes 12 acres of land and all associated buildings, structures and other improvements, through an option in its existing lease with the original owners. Abiomed […]

Apple to launch heart arrhythmia trial with Apple Watch 3

Apple (NSDQ:AAPL) said this week it will partner with telemedicine company American Well and Stanford University to test the performance of its Series 3 Apple Watch to detect heart arrhythmias, according to a Fortune report. The tech giant announced the Apple Heart Study at its iPhone unveiling event earlier this week, saying that the company would […]

LivaNova heater-cooler implicated in 12 pediatric heart surgery infections

A dozen children who underwent cardiac procedures at Children’s Hospital New Orleans earlier this year have been infected with myobacterium previously linked to LivaNova’s (NSDQ:LIVN) 3T Heater-Cooler systems, according to a STAT News report. A total of 55 children had heart surgery between May and July at the facilities, with 7 of the 12 patients […]

Smiths Medical could have a cybersecurity problem

The US Dept. of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team has released a warning over issues with Smiths Medical’s Medfusion 4000 wireless syringe infusion pump after discovering 8 cybersecurity vulnerabilities in the device. The notice is for versions 1.1, 1.5 and 1.6 Medfusion 4000 wireless syringe infusion pumps, according to the DHS […]

FDA releases final guidance on medical device interoperability

The FDA this week released final guidance on interoperability in medical devices as more and more healthcare related electronics connect to the Internet of Things. “As electronic medical devices are increasingly connected to each other and to other technology, the ability of these connected systems to safely and effectively exchange information and use information that […]

3D-printed organ developer BioLife4D seeks $50 million IPO

Biological 3D printing developer BioLife4D has filed for a $50 million initial public offering as it looks to commercialize its cardiac tissue regeneration and organ replacement processes. The Chicago-based company said yesterday it is developing technologies with an end goal of creating a 3D bioprinted viable human heart suitable for transplant. Funds from the offering

NuVasive wins FDA nod for redesigned Magec system

NuVasive Inc. (NSDQ:NUVA) said today it won FDA 510(k) clearance for its redesigned Magec magnetically controlled growth modulation system. The San Diego, Calif.-based company’s Magec system uses magnetic technology and adjustable growth rods to treat early-onset scoliosis, and features the company’s Reline small stature system. The Reline small stature platform is a pediatric deformity fixation system which […]

GI Dynamics CEO is optimistic about Endobarrier’s future: Here’s why

GI Dynamics (ASX:GID) CEO Scott Schorer has had an uphill battle over the past year. His company has faced regulatory and compliance issues, negative shareholder sentiment and a number of other concerns. But Schorer and his team are committed to righting the ship and saving a product they see as having no equal in the current

Exthera Medical wins FDA EAP designation for Seraph 100 blood filter

Exthera Medical said today that the FDA granted its Seraph 100 blood filter an expedited access pathway designation. The approval comes with an initial indication for use “as an adjunctive treatment for bacteremia in addition to antibiotics for patients receiving hemodialysis when the source of the infection is heparin- or heparin sulfate-binding bacteria, including antibiotic […]

New retinal imaging tech promises to help diagnose Alzheimer’s

New technology, developed by NeuroVision Imaging and Cedars-Sinai, is exploring the use of noninvasive eye imaging to detect Alzheimers disease, scanning the retina to identify protein deposits associated with the disorder. The system is designed to look for neurotoxic beta-amyloid protein deposits, which are also found in the brain in Alzheimers patients. Normally, such deposits

Stratasys shares steady on Q2 beat

Shares in Stratasys have fallen slightly today, even as the 3D printing and additive manufacturing company met expectations on Wall Street with its second quarter earnings results. The Eden Prairie, Minn.–based company posted losses of $6.2 million, or 11¢ per share, on sales of $170 million for the 3 months ended June 30, seeing losses

Avinger shares slide on Q2 miss

Shares in Avinger (NSDQ:AVGR) fell today after the medical device developer missed expectations on Wall Street with its second quarter earnings results. The Redwood City, Calif.-based company posted losses of $12.8 million, or 54¢ per share, on sales of $2.5 million for the 3 months ended June 30, seeing losses shrink 5.2% while sales shrunk 47.5% compared

Bionik Labs integrates Amazon voice control tech into Arke lower body exoskeleton

Robotic rehabilitation device developer Bionik Laboratories said it integrated Amazon‘s (NSDQ:AMZN) Echo and Alexa voice technology into its Arke lower body exoskeleton. With the integration users of the Arke exoskeleton will be able to control the system and its various activity modes, including standing and walking, through voice commands, the Toronto-based company said. Read the whole story on

Why the medtech contract manufacturing M&A trend isn’t slowing down

Consolidation is increasingly shaping the medical device industry, but what about players on the other side of the fence? Contract manufacturing partners to OEMs are seeing their own abundance of M&A as larger players look to expand their influence and keep up with increasing demand. Over the past four years, the medical device industry has