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BioWorld - Tuesday, April 14, 2026
Home » Topics » Medical technology, Regulatory

Medical technology, Regulatory
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Architectural pillars

US Supreme Court says no to Takeda class action challenge

March 23, 2026
By Mari Serebrov
No Comments
Crushing the hopes of drug and device companies, the U.S. Supreme Court’s March 23 orders list showed it denied cert in Takeda Pharmaceutical v. Painters & Allied Trades, which sought to rein in the expansion of class action lawsuits.
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Boston Scientific Cryoablation System

NICE issues guidance to improve kidney cancer care

March 23, 2026
By Shani Alexander
No Comments
With incidence of kidney cancer rising in the U.K., the National Institute for Health and Care Excellence (NICE) published its first comprehensive guidelines for diagnosing and treating the disease.
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Minimed Flex system

Minimed secures FDA nod for next-gen insulin pump

March 19, 2026
By Shani Alexander
No Comments
Minimed Group Inc. secured U.S. FDA approval for Minimed Flex, its next-generation discreet, smartphone-controlled insulin pump. The nod from the FDA follows the company’s debut on Nasdaq March 6. About half the size of the Minimed 780G pump and roughly the size of two stacked insulin vials, the screenless pump was designed in collaboration with people living with diabetes to offer a more intuitive, lifestyle‑friendly way to manage the condition.
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Elecsys Apolipoprotein E4 (ApoE4) biomarker test

Roche secures CE mark for blood test to identify ApoE4 carriers

March 17, 2026
By Shani Alexander
No Comments
Roche Holding AG received CE Mark approval for its Elecsys Apolipoprotein E4 (ApoE4) biomarker test, an in vitro diagnostic immunoassay to identify the ApoE4 gene variant from a blood sample. With APOE4 considered as the strongest genetic risk factor for developing Alzheimer’s disease, the test provides a fast, reliable way to determine whether an individual carries the genetic variant without the need for DNA‑based genotyping.
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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
No Comments
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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