OtoNexus (Seattle) has raised more than $4.4 million as it continues to develop its ultrasound medical device technology to diagnose middle ear infections, according to a U.S. Securities and Exchange Commission Form D filed this month. OtoNexus has been seeking a nearly $8.3 million from the money-raise. It previously raised $7.8 million in 2017. Get the full […]
Bioventus launches Osteomatrix+ bone graft
Bioventus announced today that it has started selling Osteomatrix+ – a moldable bone graft substitute intended for a variety of orthopedic and spine bone remodeling applications. Bioventus officials boast that Osteomatrix+ has improved moldability, flexibility and versatility versus its predecessor. “Osteomatrix+ represents the first of several next-generation products that will be added to the Bioventus portfolio […]
5 top stories that mattered for medtech in 2018
The medical device industry faced some major challenges over the past year, from increased media scrutiny to regulatory uncertainty in both the U.S. and E.U. It’s worth noting, though, that many things have been going right for medtech. More than half of the roughly 100 largest medical device companies in the world saw their stock […]
Presbia reaches ISO medical device quality milestone
Presbia (Nasdaq:LENS) said today that it has successfully completed the ISO 13485:2016 audit with no major findings. Officials at the Dublin, Ireland–based ophthalmic device company described the audit completion as an essential step toward recertifying under the ISO standard. The company – which has administrative offices and manufacturing in Irvine, Calif. – will receive annual surveillance […]
Inspire Medical Systems scores win with Blue Cross Blue Shield Association
Inspire Medical Systems – creator of a pacemaker-like system to treat obstructive sleep apnea – said today that the Blue Cross Blue Shield Association’s Evidence Street issued a positive assessment of Inspire therapy to its members. BCBSA is a national federation of 36 Blue Cross and Blue Shield companies. The report from BCBSA, according to Inspire […]
IRRAS: Intracranial bleeding management device used on first U.S. patient
IRRAS AB announced today that a healthcare team in Southern California is the first to use the company’s IRRAflow device on a U.S. patient with intracranial bleeding. A University of California–Irvine (UCI) Medical Center team led by Dr. Sumeet Vadera successfully treated a patient who suffered a chronic subdural hematoma after a recent fall. The IRRAflow device – FDA […]
Monteris Medical had a serious recall: Here’s what their CEO did
Soon after Marty Emerson took over as CEO of Monteris Medical, he and other company officials realized that the company’s robot-assisted brain surgery device had a serious overheating problem. Here’s how he led the company through the crisis. Marty Emerson became CEO of Monteris Medical (Plymouth, Minn.) in July 2016. Within a month, the first […]
Here are 5 medtech industry trends you need to know
Whether it’s the slew of mergers and acquisitions or tighter regulation, developments of recent years are having some surprising effects on the medtech industry, according to experts. Money is tight, the largest medical device companies are merging and it’s hard to see where regulation is going – medtech insiders have heard about such trends for years. […]
Monteris Medical expands access to NeuroBlate System with Anthem win
On the heels of a coverage update from health insurance giant Aetna, Monteris Medical has achieved a similar win from Anthem when it comes to epilepsy patients gaining access to Monteris’ NeuroBlate system. Anthem’s clinical utilization management guidelines for laser interstitial thermotherapy, which Monteris announced today, allows Anthem beneficiaries with refractory epilepsy to access the minimally invasive […]
Medical IoT and the security challenges for healthcare: What you need to know
What do healthcare providers want from medical device manufacturers concerning network and device security? Martin Nappi, Green Hills Software The advent of the Internet of Things (IoT) has created enormous opportunity and profound challenges for any business looking to take on the digital transformation. But no industry faces more of a test to make this change […]
Medical device industry regulation is changing: What you need to know
The medical device industry has been taking a lot of heat lately when it comes to patient safety. There’s the recent International Consortium of Investigative Journalists’ “Implant Files” report, as well as the documentary “Bleeding Edge” on Netflix. Both paint a picture of lax medical device regulation resulting in patients exposed to poorly tested implants. Veteran regulatory […]
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