Medical devices have had to deal with a large body of uncertainty where patent protection is concerned, thanks principally to jurisprudence arising out of the Supreme Court. However, Mark Mansour, a regulatory attorney with the D.C. office of Dykema Gossett PLLC, said on a recent webinar that even in the absence of a patent, de novo devices can gain some market exclusivity with smart use of labeling, a practice that can help ensure that the developer can achieve the needed return on investment.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Guardant Health, Intelligent Implants, Thermo Fisher Scientific.
Lantheus Holdings Inc. has snagged FDA approval for Pylarify (piflufolastat F 18), a PET imaging agent for the identification of suspected metastasis or recurrence of prostate cancer. The company said the product will be available immediately in the mid-Atlantic and southern regions, with availability across the U.S. by the end of 2021.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acutus Medical, Advanced Human Imaging, Avicenna.AI, Lantheus, Micro Interventional Devices, Nowdiagnostics.
In an effort to address the longstanding issues with medical device manufacturers failing to comply with Section 522 postmarket surveillance studies, the FDA is looking to revamp 2016 policies in new draft guidance issued on Wednesday. A separate FDA draft document seeks to update guidance on post-approval study requirements for high-risk devices with new policies on procedures and submissions.
The official compliance date for the European Union’s Medical Device Regulation (MDR) is now officially in force after a delay of two years. One of a number of unfortunate side effects is that the mutual recognition agreement (MRA) between the EU and the Swiss government has lapsed, and the European Commission has indicated that the two sides have not come to terms over the impasse.
Woebot Labs Inc. got a bit of a pick-me-up with the FDA's decision to grant breakthrough device designation to the company's digital therapeutic for postpartum depression. The WB001 app combines cognitive behavioral therapy with interpersonal psychotherapy and an understanding of how postpartum depression affects interactions and daily life. The investigational treatment is designed as an eight-week, prescription-only intervention for women under a physician’s care.
LONDON – Ibex Medical Analytics Ltd. has secured a second CE marking for its Galen artificial intelligence decision support system for automated interpretation of tumor biopsies, adding breast cancer to the approval in prostate cancer secured just over a year ago. The CE mark follows results from a blinded, multicenter clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel. Ibex says that in the trial Galen breast demonstrated very high accuracy in detecting various types of breast cancer.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bimini Health Tech, Ibex, Koya Medical, One Drop, Pentax Medical, Turner Imaging Systems, Varian, Visionairy Health, Xandar Kardian.