Avinger (NSDQ:AVGR) said today that it won FDA 510(k) clearance for its Pantheris SV small vessel image-guided atherectomy system. The Pantheris SV is an extension of the Redwood City, Calif.-based company’s lumivascular image-guided atherectomy platform which it hopes will expand the available market for its Pantheris devices by up to 50%. The newly cleared device features a […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Health Canada notifies Allergan on intent to suspend Biocell breast implant license
Health Canada said yesterday that it plans to suspend Allergan‘s (NYSE: AGN) licenses to sell its Biocell breast implants in the region due to a possible association with a rare immune system-cancer. The move follows the agency’s completion of a scientific assessment of macro-textured implants, which it said is part of a larger safety review of […]
Australia’s TGA looks to strengthen medical device oversight
Australia’s Therapeutic Goods Administration yesterday released a three-part action plan looking to strengthen the company’s medical device regulatory system. The plan includes steps to improve oversight of new devices entering the market, strengthening post-market monitoring and providing more device information to patients. The changes are slated to take effect in early-to-mid 2019 and continue into […]
Report: France to ban textured breast implants
France is planning to ban textured breast implants, which have been linked a rare immune-system cancer, according to a report from France24. France’s National Agency for Medicines and Health Products began informing manufacturers on April 2 of its plans to ban manufacturing, distribution, importing, exporting, promotion and wearing of textured breast implants and polyurethane breast […]
Presbia delays Flexivue Microlens FDA PMA approval timeline again
Presbia (NSDQ:LENS) has delayed the timeline for approval of its Flexivue Microlens for treating far-sightedness again due to an earlier request for more information from the FDA. The Irvine, Calif.-based company was told last October that it had 180 days to provide the agency with 36-month data from all subjects enrolled in the staged pivotal clinical […]
Report: Ex-FDA head Gottlieb to join conservative think tank
Departing FDA Commissioner Dr. Scott Gottlieb is returning to the conservative think tank American Enterprise Institute to focus on solutions to drug pricing issues, according to a report from The Hill. Gottlieb will serve as a resident fellow at the Washington-based group, spending six days a month at its facilities in Washington D.C., according to […]
Orthofix Medical touts data from artificial disc study
A study of patients implanted with Orthofix Medical’s (NSDQ:OFIX) M6-C artificial cervical disc showed a significant improvement in neck and arm pain, function and quality of life scores, the company said today. Patients in the investigational device exemption (IDE) study also used less pain and opioid medication when compared with anterior cervical discectomy and fusion […]
TherOx wins FDA approval for SuperSaturated Oxygen therapy
TherOx said today that it won pre-market approval from the FDA for its SuperSaturated Oxygen Therapy system for acute myocardial infarction. Irvine, Calif.-based TherOx touted the PMA as the first heart attack treatment approved to reduce infarct size since the federal safety watchdog OK’d percutaneous coronary interventions. Indicated for patients suffering from left anterior descending […]
Avanos Medical wins FDA nod for ON-Q Bolus pump
Avanos Medical (NYSE: AVNS), which rebranded from Halyard Health last June, said today that it won FDA 510(k) clearance for its ON-Q* with Bolus pump drug infusion device. The Alpharetta, Ga.-based company said that the new ON-Q* with Bolus system features improvements to improve ease of use and reduce postoperative opioid use for pain management. Read the whole story […]
FDA nixes Evoke Pharma’s gastro nasal spray
The FDA has rejected Evoke Pharma’s (NSDQ:EVOK) application for a metoclopramide nasal spray for diabetic women with gastroparesis. The Solana Beach, Calif. company’s stock price tumbled 40% on the news yesterday that the agency had found dosing inconsistencies in the pivotal pharmacokinetic study for the spray, Gimoti. In an earlier multi-disciplinary letter to the company, […]
Cigna lowers insulin price to $25 per month
Under pressure from patients and the FDA, Cigna (NYSE:CI) and Express Scripts said today that they will lower the price of insulin to $25 per month for some patients. Three firms — Eli Lilly, Novo Nordisk and Sanofi — control 90% of the global insulin market and produce all the insulin used in the U.S. […]