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BioWorld - Sunday, March 15, 2026
Home » Topics » Medical technology, Regulatory

Medical technology, Regulatory
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Red error exclamation point over binary code background

US med-tech company begins restoration after cyber strike

March 12, 2026
By Mari Serebrov
No Comments
Stryker Corp. is scrambling to recover from a cyberattack that’s disrupting its global network and being claimed by pro-Iranian hackers. “At this time, there is no indication of malware or ransomware, and we believe the situation is contained to our internal Microsoft environment only,” the Kalamazoo, Mich.-based med-tech company said March 12.
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Laptop, stethoscope, medical icons, health professional

ARPA-H sets sights on next-gen biosensors

March 11, 2026
No Comments
The Advanced Research Projects Agency for Health (ARPA-H) launched its Delphi program March 10 to advance the development of the next generation of wearable and ingestible biosensors that can securely report deep biological data to optimize health care.
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Laptop displaying FDA logo

FDA unifying, modernizing adverse event reporting system

March 11, 2026
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The U.S. FDA has begun moving its patchwork of adverse event (AE) reporting systems into a single, intuitive AE platform that will cover all its centers.
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Fallopian tubes, ovaries and uterus

China approves first noninvasive therapy for cervical precancer

March 10, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration has approved Asieris Pharmaceuticals Co. Ltd.’s cold light photodynamic drug-device combination product, Cevira (APL-1702, hexaminolevulinate hydrochloride), which is used as a nonsurgical therapy for treating patients with cervical intraepithelial neoplasia grade 2.
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Korea ARPA-H roundtable

Korean ARPA-H to invest ₩162B in nine projects in 2026

March 10, 2026
By Marian (YoonJee) Chu
No Comments
The K-health MIRAE Initiative, also known as Korean ARPA-H, announced plans to allocate about ₩162 billion (US$110 million) in nine new projects over the next five years, with a focus on strengthening national health security.
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Erbe recalls bursting Cryoprobes

March 10, 2026
No Comments
The U.S. FDA released an early alert March 10 regarding the rupturing or bursting of certain Erbe USA Cryoprobes when they’re activated. Meanwhile, the company is voluntarily recalling the affected Erbe Flexible Cryoprobes, which use extreme cold and cryoadhesion for procedures such as the removal of blood clots, necrotic tissue, and tissue tumors and biopsies.
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Med-tech fraud charges lead to prison time

March 9, 2026
By Mari Serebrov
No Comments
Patrick Cassells, of Fulshear, Texas, was sentenced March 6 to more than seven years in prison and ordered to pay more than $25 million in restitution and forfeiture after he pleaded guilty nearly two years ago to one count of health care fraud that involved the three durable medical equipment companies he owned and operated.
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Claire, an AI-powered imaging device

Perimeter gets FDA nod for imaging device for breast cancer surgery

March 6, 2026
By Shani Alexander
No Comments
Perimeter Medical Imaging AI Inc. secured FDA premarket approval for Claire, its AI-powered imaging device which detects difficult-to-see cancer during breast-conserving surgery. Claire combines AI with wide-field optical coherence tomography to provide surgeons with high-resolution, real-time views of excised tumor margins, to reduce the need for re-operations.
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Korea ARPA-H roundtable

Korean ARPA-H to invest ₩162B in nine projects in 2026

March 6, 2026
By Marian (YoonJee) Chu
No Comments
The K-health MIRAE Initiative, also known as Korean ARPA-H, announced plans to allocate about ₩162 billion (US$110 million) in nine new projects over the next five years, with a focus on strengthening national health security.
Read More
Fallopian tubes, ovaries and uterus

China approves first noninvasive therapy for cervical precancer

March 4, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration has approved Asieris Pharmaceuticals Co. Ltd.’s cold light photodynamic drug-device combination product, Cevira (APL-1702, hexaminolevulinate hydrochloride), which is used as a nonsurgical therapy for treating patients with cervical intraepithelial neoplasia grade 2.
Read More
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