Shares in Pavmed Inc. (NSDQ:PAVM) rose today after the medical device maker beat expectations on Wall Street with its third quarter results. The N.Y.-based company posted a net loss of -$5.37 million, or -40¢ per share, for the 3 months ended Sept. 30, for bottom-line loss of -178.5% compared with the same period last year. Get the […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
House passes DoD bill with room to renegotiate drug, device approval provision
The US House of Representatives this week passed a nearly $700 billion defense policy bill, but left room for negotiating new terms related to a controversial provision which would have given the Dept. of Defense the power to approve medical devices and drugs without FDA clearance. The house voted 356 to 70 to approve the […]
Bigfoot Biomedical CEO hits back against CMS over data-sharing decision
Bigfoot Biomedical CEO Jeffrey Brewer has spoken out about a recent data-sharing decision made by CMS, saying that he plans to lobby Medicare to reverse its latest move. Earlier this year, CMS said it would begin covering the use of particular continuous glucose monitors for people with diabetes. But since that decision, the agency has said that […]
BioCorRx inks deal with Nat’l Institute on Drug Abuse
BioCorRx (OTC:BICX) said today that it inked a confidentiality agreement with the National Institute on Drug Abuse, which will allow the group to share information and potentially work together on R&D and commercialization of BioCorRx’s therapies for opioid use disorder. The National Institutes of Health division has also agreed to participate as an observer at the […]
EBR Systems pulls in $50m for wireless pacer
EBR Systems said yesterday that it raised $50 million to back a clinical trial for the wireless cardiac pacemaker it’s developing after winning CE Mark approval for a second-generation wireless transmitter. EBR’s device, which it calls wireless stimulation endocardially or Wise, uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the […]
Scilex seeks EU nod for ZTlido lidocaine patch
Sorrento Therapeutics (NSDQ:SRNE) subsidiary Scilex Pharmaceuticals said today that it filed a marketing authorization application seeking approval for its ZTlido lidocaine patch. The San Diego, Calif.-based company said it is pursuing a hybrid regulatory pathway with the Medicines and Healthcare Products Regulatory Agency in the U.K., which will serve as the lead review agency. The company also plans to file […]
Corvia Medical launches Interatrial Shunt Device heart failure trial
Update: Corrected from previously mislabeled ‘interarterial’ to ‘interatrial’ shunts Corvia Medical said today it launched the Reduce LAP-HF II clinical trial of its transcatheter Interatrial Shunt Device designed to treat heart failure as it seeks FDA approval of the device. The Tewksbury, Mass.-based company said the 1st patient in the trial was enrolled by Dr. Rami Kahwash […]
MedShape wins FDA nod for DynaNail XL TTC fusion system
MedShape said today it won FDA 510(k) clearance for its DynaNail XL TTC fusion system designed for tibiotalocalcaneal fusion surgery. The DynaNail XL TTC system is designed to better accommodate patients with longer tibial anatomies and treat tibial fractures, the Atlanta-based company said. The system is available in 260 mm and 300 mm lengths and includes […]
RTI Surgical reveals FDA warning letter over Map3 allograft classification
RTI Surgical (NSDQ:RTIX) today revealed a warning letter it received from the FDA related to processes used to manufacture its Map3 cellular allogeneic bone graft over issues with the regulatory classification of the product. The Alachua, Fla.-based company said it received the letter on November 9 based on an inspection of its facilities from April and […]
FDA approves first pill with sensor to track ingestion
The FDA today approved Abilify MyCite, the first drug in the U.S. to have an ingestible sensor embedded within the pill that can track if the medication was taken. The drug-device combination product is indicated for the treatment of schizophrenia, acute treatment of manic and mixed episodes linked with bipolar I disorder and as an […]
Orthocell wins CE Mark for CelGro device
Orthocell (ASX:OCC) said today that its CelGro collagen medical device won CE Mark approval for a range of dental bone and soft tissue regeneration procedures. The company said it’s in talks with the strategic commercial partners to distribute its product throughout Europe and other key regions. Orthocell is also reportedly holding discussions with key opinion leaders […]