Nine weeks after hurricanes Maria and Irma brought devastation to Puerto Rico, FDA commissioner Dr. Scott Gottlieb says hospitals across the U.S. are reporting shortages of IV fluids – medical products that are often sourced from Puerto Rico. Hospitals are specifically noting that 0.9% injection bags of saline, used to inject drugs intravenously, are of […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
7 medtech stories we missed this week: Nov. 17, 2017
From Skyline Medical’s joint venture to Lensar receiving FDA clearance and CE Mark, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Skyline Medical launches JV deal with Helomics Skyline Medical announced in a Nov. 15 press release that it has signed a joint venture agreement with Helomics. […]
Alcyone Lifesciences wins FDA nod for Alivio hydrocephalus shunt flusher
Alcyone Lifesciences said yesterday it won FDA 510(k) clearance for its Alivio ventricular catheter and flusher system designed for treating hydrocephalus. The newly cleared Alivio device is designed for the non-invasive retrograde flushing of the ventricular catheter to unblock occluded inlet holes or open a relief membrane to restore or increase cerebrospinal fluid flow in […]
Insulia wins FDA nod, CE Mark clearance to titrate Tresiba, Basaglar insulin
Voluntis said today that its digital management system for people with Type II diabetes, Insulia, won FDA clearance and CE Mark approval to integrate basal insulin brands Tresiba and Basaglar. The company’s software already works with Lantus, Toujeo and Levemir. The Insulia digital companion is composed of a patient mobile app and healthcare worker web portal. […]
Varian Medical wins Japanese nod for Halcyon oncology radiotherapy system
Varian Medical (NYSE:VAR) said today it won Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its Halcyon image-guided volumetric intensity modulated radiotherapy cancer treatment system. The Palo Alto, Calif.-based company said its Halcyon IMRT system features improvements that make it more comfortable for patients and streamline operator’s workflow, only requiring 9 steps […]
House approves FDA fast track for battlefield treatments
The U.S. House of Representatives yesterday approved a measure that would create a fast track at the FDA for medical devices and drugs intended for treating battlefield injuries, a day after passing a nearly $700 billion defense policy bill that would have allowed Defense Dept. to approve the treatments without the FDA’s participation. That provision […]
TSO3 responds to FDA info request for Sterizone VP4 duoedenoscope indications
TSO3 (TSE:TOS) said today it responded to a request for additional information from the FDA on its Sterizone VP4 sterilizer as it seeks an indication for the terminal sterilization of duodenoscopes. The company’s Sterizone VP4 is a low-temperature sterilization system which uses dual-sterilants of vaporized hydrogen peroxide and ozone for the terminal sterilization of heat and […]
Nevro wins MR-conditional CE Mark for Senza spinal cord stim
Nevro Corp. (NYSE:NVRO) yesterday said it won MR-conditional CE Mark approval in the European Union for its Senza spinal cord stimulator for treating chronic pain. The retroactive approval applies to all patients implanted with the Senza device, which was previously CE Marked for head and extremity MRI scans, according to the Redwood City, Calif.-based company. Senza, […]
FDA clears Innovative Health Solutions opioid withdrawal treating neuromod
Innovative Health Solutions won FDA clearance for a new indication for its NSS-2 Bridge device, now cleared to reduce symptoms of opioid withdrawal, according to an FDA release. The NSS-2 Bridge device is a small electrical nerve stimulator designed to be placed behind a patient’s ear and emit electrical pulses to stimulate branches of certain […]
Pavmed shares climb after Q3 EPS beat
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 […]
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 […]