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Illustration of male vs. female bodies showing organs

FDA eyes update to 2014 guidance on sex-specific study considerations

Jan. 14, 2025
By Mark McCarty
The U.S. FDA posted a draft guidance that would revisit a 2014 final guidance on sex-specific data drawn from medical device clinical trials, expanding the scope to include considerations of gender.
Read More
Neurons with dendrites affected by amyloid plaques in Alzheimer's disease
JPM Healthcare Conference

Sunbird Bio soars into neurodegenerative diagnostic space

Jan. 14, 2025
By Holland Johnson
As 2025 makes its debut, one of the topics gaining momentum in health care is the diagnosis and potential treatment of neurodegenerative diseases, a scourge that threatens to overwhelm society and drain treatment budgets around the world. One company looking to find solutions to the oncoming neurodegenerative disease tsunami is privately held Sunbird Bio Inc., which is developing blood-based diagnostic platform for neurological diseases like Alzheimer’s and Parkinson’s disease.
Read More
3D map of China

European Commission pushes back on Beijing’s med-tech policy

Jan. 14, 2025
By Mark McCarty
Beijing’s policy of favoring domestic medical technology is a matter of record, but the European Commission apparently heard enough from EU med tech firms to take action. The Commission posted notice that it may take steps to retaliate by restricting bids from China for EU government contracts in retaliation, a move certain to draw cheers from European device makers.
Read More
Recor Medicaal Paradise renal denervation catheter

CMS opens national coverage analysis for renal denervation

Jan. 14, 2025
By Mark McCarty
U.S. Medicare coverage of renal denervation (RDN) for uncontrolled hypertension may soon be a fact of life if the manufacturers of these systems have their way. CMS opened a national coverage analysis for RDN, but as is routine practice recently, the agency is asking for comment before posting even a draft coverage memo for this technology.
Read More
Immuno-oncology art concept
Immuno-oncology

Rise Therapeutics’ R-5780 gains IND clearance from FDA

Jan. 14, 2025
Rise Therapeutics LLC has gained IND clearance from the FDA to initiate a phase I trial of R-5780 in patients with cancer.
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Stem cells
Neurology/psychiatric

Ips Heart’s stem cell therapy designated orphan drug for Becker muscular dystrophy

Jan. 14, 2025
Ips Heart Inc. has been awarded orphan drug designation by the FDA for its GIVI-MPC stem cell therapy for Becker muscular dystrophy. GIVI-MPC has the unique ability to create new muscle with full length dystrophin in Becker muscular dystrophy.
Read More
Close-up of elderly eye
Ocular

Pulsesight seeks clinical trial clearance for PST-611 for dry AMD/geographic atrophy

Jan. 14, 2025
Pulsesight Therapeutics SAS has submitted a clinical trial authorization (CTA) to the French authority ANSM seeking to conduct a first-in-human phase I trial of PST-611 for dry age-related macular degeneration (AMD)/geographic atrophy (GA).
Read More
Laptop displaying FDA logo

Industry blasts FDA for requiring full ASCA conformity test reports

Jan. 13, 2025
By Mark McCarty
The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program has its benefits, but industry had some sharp words for the agency in commenting on the 2024 ASCA draft guidance. The Advanced Medical Technology Association stated that FDA reviewers asked for full conformity test results for roughly 5% of premarket applications, a rate seen as excessive given the program’s design.
Read More
Illustration of male vs. female bodies showing organs

FDA eyes update to 2014 guidance on sex-specific study considerations

Jan. 13, 2025
By Mark McCarty
The U.S. FDA posted a draft guidance that would revisit a 2014 final guidance on sex-specific data drawn from medical device clinical trials, expanding the scope to include considerations of gender.
Read More
Medtronic adaptive DBS System

​Medtronic‘s Brainsense lands CE mark for Parkinson’s

Jan. 13, 2025
By Shani Alexander
Medtronic plc secured CE mark approval under the EU Medical Device Regulation for its Brainsense adaptive deep brain stimulation system. The technology represents a major advancement in the treatment of Parkinson’s disease as it provides real-time, self-adjusting brain stimulation based on the patient’s brain activity, offering a more personalized therapy.
Read More
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