A liquid biopsy assay that incorporates multiple companion diagnostics has gotten a boost from the FDA. Cambridge, Mass.-based Foundation Medicine Inc. reported that the agency had granted a breakthrough device designation for an expanded version of its FoundationACT (Assay for Circulating Tumor DNA) assay, which would include more than 70 genes and genomic biomarkers for microsatellite instability and blood tumor mutational burden.
Boston Scientific Corp. (NYSE:BSX) was on the rise Wednesday after posting first-quarter results that beat expectations. The Marlborough, Mass.-based company also reported that it was raising its 2018 revenue guidance range to $9.75 billion to $9.9 billion, up from a predicted $9.65 billion to $9.8 billion. The company closed at $29.42 after opening at $28.35.
A day ahead of its first-quarter earnings call, Boston Scientific Corp. touted one-year data from the INTREPID study, which evaluated its Vercise direct brain stimulation (DBS) system to treat the symptoms of Parkinson's disease. Among the data highlights was an overall sustained improvement in quality of life.
As it works to ramp up its U.K.-based oncology centers, Proton Partners International Ltd. has agreed to buy magnetic resonance (MR)-linac systems from Stockholm-based Elekta. The order is valued at £25 million (US$34.9 million), with the agreement
Santa Barbara, Calif.-based Sientra Inc. (NASDAQ: SIEN) scored a big win this week, with the company reporting after the market closed Wednesday that the FDA had approved a final process enhancement for a manufacturing facility. As a result, Sientra is poising to regain market share with its Opus-branded breast implant products and ending an ordeal spawned by an inspection of a contract manufacturer in Brazil. Sientra closed at $11.98 Thursday after closing at $11.05 the previous day.
Establishing a more modern 510(k) pathway, proposing a postmarket authority related to the disclosure of cyber-vulnerabilities, and improving the quality of real-world evidence generation for technologies that address women's health are three proposals the FDA has put forward as it looks to enhance the safety of medical devices throughout the total product lifecycle (TPLC).
With 2016 wrapping up, Irvine, Calif.-based Endologix Inc., is facing another challenge in the form of a temporary hold on shipments of its AFX endovascular abdominal aortic aneurysm system due to a manufacturing problem. The hold comes shortly after the company had its CE mark for AFX suspended, as well as the receipt of an FDA request for two-year patient follow-up data for the Nellix endovascular aneurysm sealing system.
