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Regulatory
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3D illustration showing presence of tumor inside prostate gland

Profound snags FDA clearance for prostate disease contouring module

May 14, 2024
By Annette Boyle
Profound Medical Corp. received U.S. FDA 510(k) clearance for its second transurethral ultrasound ablation (TULSA) module using artificial intelligence. When used with Profound’s TULSA-Pro system, the Contouring assistant helps physicians more quickly and accurately segment prostate imaging and design treatments.
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NIH researcher looking through a microscope

Sen. Cassidy calls for NIH reforms, questions US ROI

May 13, 2024
By Mari Serebrov
Is the U.S. getting the best return on investment (ROI) for its NIH buck? That’s the basic question at the heart of a white paper Sen. Bill Cassidy (R-La.) issued May 9 to continue a conversation he started in September on the reforms needed at the country’s premier biomedical research institution.
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Magnifying glass, FDA concept image

Bioptimal hit with US FDA warning for uncleared changes to catheters

May 13, 2024
By Mark McCarty
The U.S. FDA has taken off the gloves when it comes to device warning letters. One recent example is the April 3 warning letter to Bioptimal International Ltd., of Shenzen, China, which did not score well with the agency on routine good manufacturing practices. Perhaps more conspicuous was that the company was selling catheters that had undergone significant changes without a new regulatory filing – a seemingly common theme in recent FDA device warning letters.
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Product recall concept image

Route 92 Medical microcatheter recall due to contract manufacturer

May 13, 2024
By Mark McCarty
Route 92 Medical Inc., of San Mateo, Calif., reported a class I recall of nearly 1,000 microcatheters because of reports of separation of the distal tip of the catheter, which is associated with two injuries and one reported death. The company indicated that the problematic catheters had been manufactured by an unidentified contract supplier, once again highlightingthe hazards of a failure to properly oversee the contract manufacture of critical medical devices.
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Lab sample and bone marrow illustration
Cancer

Ajax Therapeutics’ type II JAK2 inhibitor cleared to enter clinic for myelofibrosis

May 13, 2024
Ajax Therapeutics Inc. has received clearance for its IND application from the FDA to initiate a phase I study of AJ1‑11095, a first-in-class type II JAK2 inhibitor, for the treatment of patients with myelofibrosis.
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Capsules in blister packs

UK expands subscription model on antibiotic pilot program success

May 10, 2024
By Nuala Moran
The U.K.’s world-first subscription model for antimicrobials is to be expanded following a successful pilot scheme in which companies are being paid a fixed annual fee for their drugs, regardless of the volume dispensed.
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Vials of SNB-101

SN Bioscience nabs FDA fast track for lung cancer drug

May 10, 2024
By Marian (YoonJee) Chu
SN Bioscience Co. Ltd., headquartered in Seongnam-si, Gyeonggi-do’s second Pangyo Valley, gained U.S. FDA fast track designation for SNB-101 (SN-38), its new polymer nanoparticle cancer drug candidate for small-cell lung cancer.
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U.S. flag on columned building

US FDA concessions on LDTs may blunt appetite for legislation

May 10, 2024
By Mark McCarty
The U.S. FDA’s final rule for lab-developed tests was a long time in coming even if the agency shorted the public comment period for the draft rule, and the final rule makes several major concessions about circumstances in which the agency would exercise enforcement discretion.
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Ribbons of digital data
Newco News

Enlitic‘s AI tools help drain the imaging quagmire

May 10, 2024
By Tamra Sami
Imaging is the number one way physicians track cancer progression and burdens within neurology and cardiology, but the ability to take imaging information and interact with it to make better decisions is becoming ever more complicated.
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Meeting illustration

US FDA adcoms turn the corner on pandemic

May 9, 2024
By Mari Serebrov
Right on cue, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) is scheduling its first in-person advisory committee meetings since the COVID-19 pandemic. Speaking during a May 6 webinar hosted by the Alliance for a Stronger FDA, CDER Director Patrizia Cavazzoni said the center was preparing to go back to in-person adcoms, adding that the first step likely would be a hybrid model.
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