Cala Health and Cue Health (Nasdaq:HLTH) both recently filed with the state of California to confirm reductions in their workforces. The two companies are the latest to join the long list of medtech companies cutting employees amid a challenging time for the industry. To date, MassDevice has reported on more than 18,000 medtech employees who have been […]
Genomics/Molecular Diagnostics
FDA clears AI software for MRSA diagnostics from BD
BD (NYSE:BDX) announced today that it received FDA 510(k) clearance for its new Kiestra imaging application that uses AI. The Kiestra methicillin-resistant staphylococcus aureus (MRSA) imaging application uses AI to interpret bacterial growth and release negative specimens with minimal human interaction. Franklin Lakes, New Jersey-based BD designed the Kiestra MRSA application to utilize AI to […]
BD CEO Tom Polen discusses character revealed by COVID-19 crisis
“We couldn’t be more proud of how the team really showed our values,” BD CEO Tom Polen said during a keynote at DeviceTalks Boston. Tom Polen’s original “master plan” included medical school. While preparing for the MCAT out of undergrad, he instead joined a small startup based in California. The startup grew and BD (NYSE:BDX) […]
Former Insulet exec named DermTech president and CEO
DermTech (Nasdaq:DMTK) announced today that it appointed Bret Christensen as president, CEO and a member of the board. Christensen previously served as chief commercial officer at automated insulin delivery technology developer Insulet. He departed last week as part of a handful of executive changes at the company. The new CEO succeeds Dr. John Dobak, who […]
Cue Health submits RSV molecular test to FDA for de novo clearance
Cue Health (Nasdaq:HLTH) announced today that it made a de novo submission to the FDA for clearance of its RSV molecular test. The submission aims to garner full clearance of the test for at-home and point-of-care use. According to Cue Health, no respiratory syncytial virus (RSV) tests exist on the market for home use. Pending […]
Hologic beats The Street in Q2, raises guidance
Hologic today posted second-quarter results that topped the consensus forecast despite dipping COVID-19-related sales. The Marlborough, Massachusetts-based women’s health and diagnostics company posted profits of $218.5 million. That amounts to 87¢ per share on sales of $1.03 billion for the three months ended April 1, 2023. Hologic posted a 52% bottom-line slide on a sales […]
Orange Biomed unveils at-home A1c test in the U.S.
Orange Biomed announced today that it commenced a U.S. launch as it looks to fill testing gaps for pre-diabetes and diabetes. Seoul, South Korea–based Orange Biomed operates out of Research Triangle Park, North Carolina in the U.S. The company currently has ongoing studies for its OBM rapid A1c test. It designed the glycated hemoglobin analyzer […]
Sherlock Biosciences names new chief scientific officer
Sherlock Biosciences announced today that it appointed Maurice Exner as its first chief scientific officer. Watertown, Massachusetts-based Sherlock said Exner will serve as a member of its executive leadership team. His responsibilities include driving the company’s scientific research strategy. “Maurice’s expertise in clinical diagnostics R&D will be invaluable as we ramp up development of our […]
Illumina to appeal FTC decision on Grail acquisition, aims for resolution by 2024
Illumina (Nasdaq:ILMN) announced today that it plans to appeal the Federal Trade Commission’s (FTC) decision over its acquisition of Grail. The FTC today announced that it finds the $7.1 billion acquisition “likely to substantially reduce competition” in the U.S. It would affect the research, development and commercialization of cancer tests, FTC said. In its decision, […]
Illumina launches cloud-based next-gen sequencing software
Illumina (Nasdaq:ILMN) announced today that it released its Connected Insights cloud-based software for next-generation sequencing (NGS). San Diego-based Illumina designed Connected Insights to streamline interpretation and reporting from a range of assay types. This enables labs to scale the use of NGS. They can also reduce turnaround times for clinical reporting by integrating third-party knowledge […]
BD wins FDA clearance for high-throughput infectious vaginitis diagnostic
BD (NYSE:BDX) announced today that it received FDA 510(k) clearance for its Vaginal Panel diagnostic on the COR system. The comprehensive diagnostic test directly detects the three most common infectious causes of vaginitis. It uses the BD COR, the company’s high-throughput molecular diagnostic platform for large laboratories. Franklin Lakes, New Jersey-based BD originally received marketing […]
