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Diagnostics & Healthcare News

Freudenberg Medical Opens New Global Headquarters and Facility Expansion in Massachusetts

Freudenberg Medical, member of the Freudenberg Group and a global developer and manufacturer of specialty components and finished devices for the medical device industry, has completed construction of a new medical manufacturing operation in Beverly, Massachusetts. Freudenberg Medical has established the facility...

November 10, 2020

Diagnostics & Healthcare News

Itamar Medical Wins National Sleep Foundation 2020 SleepTech Award

The National Sleep Foundation (NSF) named Itamar Medical Ltd. (NASDAQ and TASE: ITMR) winner of the 2020 SleepTech Award. The SleepTech Award recognizes the year’s most innovative efforts in advancing sleep technology. Itamar Medical is a technology company focused on the...

November 6, 2020

Diagnostics & Healthcare News

Prostate Cancer Protection Company BioProtect Raises $25M

BioProtect ltd., a private company with a unique bioabsorbable polymer spacer balloon platform, announced the final closing of $25 million of its Series D equity financing from an unnamed strategic investor and Peregrine Ventures. Every year, more than 1.1 million men are...

September 23, 2020

Diagnostics & Healthcare News

Fitbit Wins FDA 510(k) Clearance and CE Mark for ECG App

Fitbit has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as Conformité Européenne (CE)marking in the European Union, for its electrocardiogram (ECG) app to assess heart rhythm for atrial fibrillation (AFib), a condition that affects more than...

September 14, 2020

Diagnostics & Healthcare News

AdvaMed Commends Proposed CMS Rule to Cover “Breakthrough” Medical Devices

Following today’s issuance by the Centers for Medicare and Medicaid Services (CMS) of a proposed rule on Medicare coverage of innovative technologies, the Advanced Medical Technology Association (AdvaMed) issued the following statements from President and CEO Scott Whitaker and other...

September 1, 2020

Diagnostics & Healthcare News

Synchron’s Stentrode Brain-Computer Interface Receives Breakthrough Device Designation from FDA

Synchron, a neurovascular bioelectronics medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for Stentrode, a fully-implantable medical device that can translate brain activity or stimulate the nervous system from the inside...

August 31, 2020

Diagnostics & Healthcare News

Valencia Technologies Files Pre-Market Approval Application with U.S. FDA for eCoin Peripheral Neurostimulator

Valencia Technologies Corporation (“Valencia“), a private medical device company, today announced the filing of its pre-market approval (PMA) application of its eCoin® Peripheral Neurostimulator System for overactive bladder with the Food and Drug Administration (FDA). eCoin® is a first-in-kind neurostimulator providing intermittent...

August 24, 2020

Diagnostics & Healthcare News

Ceek Women’s Health Introduces Nella NuSpec, a Smarter Reusable Vaginal Speculum

Ceek Women’s Health, a groundbreaking women-led medical device company, is excited to announce its latest innovation, the Nella NuSpec Reusable Vaginal Speculum. The Nella NuSpec was developed in partnership with OBGYN providers and patients through an extensive 5-year R&D process. ...

August 17, 2020

Diagnostics & Healthcare News

MagVenture Receives FDA Clearance for OCD

FDA has cleared MagVenture TMS Therapy for adjunct treatment of Obsessive-Compulsive Disorder (OCD). This marks the second indication in the US for the Danish medical device company MagVenture who is already FDA cleared for the treatment of major depressive disorder....

August 14, 2020