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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

Cardiovascular / Cardiology

Philips to Acquire Intact Vascular for $275M

Royal Philips, a global leader in health technology, today announced that it has signed an agreement to acquire Intact Vascular, Inc., a U.S.-based developer of medical devices for minimally-invasive peripheral vascular procedures. Intact Vascular will enhance Philips’ image-guided therapy portfolio,...

August 28, 2020

Orthopedics and Spine

FDA Clears SurGenTec Synthetic Bone Graft

SurGenTec, a privately held spine and orthopedic technology company, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary OsteoFlo NanoPutty- Quadphasic Synthetic Bone Graft. OsteoFlo NanoPutty is a novel bone...

August 27, 2020

Surgery and Surgical Robotics

Hologic Buys Accessa Health for $80M

Hologic, Inc., a global leader in women’s health, announced today that it has acquired Acessa Health Inc., a privately-held innovator in minimally invasive treatment for fibroids, for approximately $80 million in cash plus contingent payments based on future revenue growth....

August 26, 2020

Surgery and Surgical Robotics

Pelvital Announces FDA Clearance of Flyte Pelvic Floor Device

Pelvital, a medical technology company focused on women’s health, announced it has received U.S. Food and Drug Administration (FDA) clearance for Flyte, a first-of-its-kind, non-invasive, intravaginal home-use device that is intended for strengthening of the pelvic floor muscles, which has...

August 25, 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

Imaging Visualization & Navigation

Hyperfine Receives FDA 510(k) Clearance for Portable MRI System

Hyperfine Research, Inc. has received 510(k) clearance from the US FDA for its category-defining portable MRI technology, the Swoop™ Portable MR imaging device. Hyperfine’s Swoop™ system is a point-of-care MR imaging device that wheels directly to the patient’s bedside, plugs into...

August 20, 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