Philips (NYSE:PHG) said it landed 510(k) clearance for its spectral breast density measurement application, a new feature for its MicroDose SI full-field digital mammography system.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Reverse Medical lands CE Mark for Barrel vascular reconstruction device
Reverse Medical said it won CE Mark approval in the European Union for its Barrel vascular reconstruction device.
The Barrel device is designed to be used with occlusive devices when treating intracranial aneurysms, according to a press release.
FDA gets serious about improving medical device innovation for kids
Baxter lands CE Mark for VIVIA multi-setting hemodialysis system
Oticon Medical lands 510(k) clearance for Ponto Plus hearing aid
Oticon Medical this week landed 510(k) clearance from the FDA for its Ponto Plus hearing device.
The Ponto Plus is a bone-anchored sound processor, designed to be used with the company’s proprietary OptiFit/OptiGrip implant design concepts. Built on Oticon’s Inium platform, the device features 2.4 GHz bluetooth wireless technology and is designed to deliver better sound quality, less feedback and fewer artificial sounds, Oticon said.
FDA walks back Regenesis contraindication
Arizona medical device maker Regenesis Biomedical won new labeling for its Provant Therapy system, removing a contraindication discouraging doctors from using the system on patients with metallic implants in the area of treatment.
The company’s Provant system uses electromagnetic energy to help manage pain and edema in soft tissues following surgery, working by spurring the body’s own pain-relief mechanisms and regulating inflammation responses.
FDA names GS1 to manage medtech identifiers | MassDevice.com On Call
MASSDEVICE ON CALL — FDA regulators appointed Belgium’s GS1 to manage its medical device Unique Device Identifier program, issuing IUDs and helping manufacturers keep up with requirements of the program.
GS1 is a not-for-profit global organization that develops and maintains what is says are the "most widely used supply chain standards in the world," affecting a variety of industries and incorporating voices from business, government, communities and other partners.
pSivida, Alimera Sciences soar as Iluvien skips ahead to FDA review
Xlumena wins FDA nod for Axios pancreatic stent
Xlumena won FDA approval to market its Axios stent and delivery system, landing approval through the FDA’s less-stringent de novo review pathway.
The stent is the 1st specifically designed for the drainage of a pancreatic pseudocyst by creating a new, temporary opening between the pancreas and the gastrointestinal tract.
Greatbatch submits PMA for spinal cord stim
Greatbatch (NYSE:GB) this week filed a pre-market approval application with the FDA for its spinal cord neuromodulation system.
The neuromodulation system comes from the Frisco, Texas-based company’s subsidiary, QiG Group, which hopes to win indication to treat chronic pain of the trunk and limbs.
FDA: Intuitive Surgical recalls are Class II
A pair of recalls affecting more than 110,000 components of Intuitive Surgical‘s (NSDQ:ISRG) flagship da Vinci surgical robot pose only a slight risk of serious consequences, the FDA said this week.