An US FDA advisory panel wasn't convinced by data for BTG/PneumRX’s Elevair Endobronchial Coil System during a June 14 meeting. The panel decided that while the emphysema device was reasonably safe, the sponsor hadn’t shown it was effective or that the benefits outweighed the risks.
BTG PLC’s Elevair Endobrochial Coil System failed in its bid for an approval recommendation from US FDA’s Anesthesiology and Respiratory Devices Panel during a June 14 meeting. Panelists said the sponsor’s data didn’t show clearly enough whether patients would see more benefit than risk from the first-of-its-kind device.
The panel voted 7-5 that the device is safe, but 5-7 against effectiveness. And only three panelists voted that the...
This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
This week, a Delaware court awarded Auris Health shareholders $1bn in a lawsuit against Johnson & Johnson; Abbott recalled some FreeStyle Libre 3 sensors; and McKesson purchased a controlling interest in a Florida cancer care chain.
Philips has filed a lawsuit against a Pennsylvania lab it hired to analyze sound abatement foam that prompted widespread recalls of its CPAP machines. Philips alleges PSN Labs grossly overestimated the risk to patients, which led Philips to initiate a larger recall than it otherwise would have.
This week, Nipro Medical Corp. announced it will invest $397.8m to build a US-based production plant, generating 232 new jobs; both Baxter and Hamilton announced ventilator recalls; Imperative Care wins FDA clearance for its stroke catheter; Intelligent Ultrasound Group plc entered into a conditional sale and purchase deal to sell its Clinical AI business to GE HealthCare for £40.5m; RMI distributed 350m rapid test kits in the fight against HIV/AIDS; Jiangsu Shenli Medical Production Co., Ltd received a second FDA warning letter about quality and safety of plastic syringes.
Biopharmaceutical giant AstraZeneca has partnered with start-up “unicorn” Owkin to develop an AI-powered tool to prescreen for gBRCA mutations on the basis of morphological features in digitized pathology slides. Built on extensive, high-quality data sourced from the France-based PortrAIt consortium, the AI will help to prioritize patients for further testing, streamlining the diagnostic process, Owkin says.
An additional $50m brings the neurovascular intervention specialist’s total Series F funding to $82m. Route 92 says it will use the capital to build its sales and support teams and pursue regulatory authorizations around the globe for its FreeClimb portfolio while advancing its SUMMIT MAX clinical trial for the investigational Monopoint Reperfusion System.
TRiCares announced first implantation of the Topaz transfemoral tricuspid heart valve replacement system as part of the company’s EU pivotal study. If all goes to plan, the device will compete with Edwards’ Evoque system. The announcement follows the company’s $50m series D funding raise in July.
