Devices

Devices

FDA Warns of Philips Ultrasound Malfunction Linked to Four Deaths

Devices

O.N. Diagnostics Warned on AI Changes to Osteoporosis Software

FDA has warned O.N. Diagnostics that it made significant changes to its VirtuOst vertebral fracture assessment software — including a new machine-learning algorithm and conversion to a web-based platform — without obtaining required agency clearance. A just-posted 9/1 Warning Letter following a March inspection of the Berkeley,

Devices

TAP Pilot Has 159 Enrolled Devices

FDA says that as of 10/7, there are 159 medical devices enrolled in the Total Product Life Cycle Advisory Program (TAP) pilot. An online update also says that on 7/1, TAP expanded to accept enrollment requests across all Offices of Health Technologies for Breakthrough-designated and Safer Technologies

Devices

FDA ‘Holistic’ Approach to QMSR

After working on over 25 medical device Form FDA-483s and Warning Letters for clients this year, attorneys Jodi Scott and Mike Heyl (Hogan Lovells Cadwalader) say it is clear that FDA has changed its approach to inspections under the QMSR to focus on a “holistic evaluation of quality system

Devices

AI Model Detects Pancreatic Cancer Before Visible on CT Scans

An artificial intelligence (AI) model detected pancreatic cancer on routine CT scans more than a year before clinical diagnosis and substantially outperformed expert radiologists in identifying early cancers that were not yet visually apparent, according to a study published in BMJ’s Gut. Researchers led by Mayo Clinic developed a

Devices

Sen. Scott Security Concerns Over Chinese Medical Devices

Senate Aging Committee chairman Rick Scott (R-FL) is raising concerns about Chinese medical device manufacturers seeking to enter the U.S. market, warning that devices capable of collecting patient information could pose cybersecurity and health-data risks. In a 10/2 letter to CMS administrator Mehmet Oz, Scott specifically

Devices

CDRH Proposed Guidances for FY 2027

CDRH has released its list of proposed guidances for FY 2027. The document separates the proposed guidances into three lists: * A List — priority guidance documents the Center intends to publish in FY 2027; * B List — guidance documents CDRH intends to publish as resources permit during FY 2027; and * Under Construction

Devices

NIH Awards Grant to Develop Blood Test for Alzheimer’s Disease

The National Institutes of Health has awarded $19.4 million for a five-year international research project aimed at developing a blood test that could determine whether Alzheimer’s disease has progressed far along to explain a patient’s cognitive symptoms and help predict future disease progression. The project, led

Devices

EBR Gets Form 483 at New WiSE Manufacturing Site

EBR Systems says FDA issued a Form 483 with two observations following an inspection of the company’s new manufacturing facility in Santa Clara, CA. The inspection is related to the agency’s review of a PMA supplement seeking to add the site as a manufacturing facility for its WiSE

Devices

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

Devices

Robotically Assisted Surgical Devices Guidance