MedGadget: Medical Device, Pharma & Healthcare News

Zolgensma cancer risk infographic showing FDA tumor investigation figures

Zolgensma Cancer Risk: FDA Confirms Gene Therapy Tumor Link in Two Children

FDA is investigating tumors after Zolgensma, confirming vector integration near the GLI1 oncogene in two children and extending the review to Itvisma.

November 12, 2026

Foundayo sleep apnea ATTAIN-OSA Phase 3 results infographic

Pharmaceutical

Foundayo Sleep Apnea Trial: Lilly’s Pill Cuts AHI by Up to 44%

Lilly's oral GLP-1 Foundayo cut sleep apnea severity by up to 43.8% in two Phase 3 ATTAIN-OSA studies, with an FDA filing for OSA planned by end of 2026.

November 11, 2026

Tandem Mobi recall infographic: 80,938 insulin pumps, 230 adverse events, FDA Class I

Medical Device

Tandem Mobi Recall: FDA Gives Class I Rating to False Occlusion Alarm Fix for 80,938 Insulin Pumps

The FDA has rated Tandem Diabetes Care's correction of 80,938 Tandem Mobi insulin pumps as Class I after false occlusion alarms paused insulin delivery; 230 adverse events have been reported.

November 11, 2026

Optune Mya FDA infographic: Not Approvable Letter, METIS trial brain metastases data

Medical Device

Optune Mya FDA Not Approvable Letter: Why Novocure Missed on Brain Metastases

The FDA issued a Not Approvable Letter for Novocure's Optune Mya in NSCLC brain metastases, citing uncertain benefit despite a positive METIS trial.

November 11, 2026

Risto-cel sickle cell pivotal BEACON results infographic

Bio Technology

Risto-cel Sickle Cell Pivotal Data: Beam Base Editing Therapy Meets Primary Goal

Beam Therapeutics says base-edited risto-cel met the BEACON primary endpoint in sickle cell disease, with 49 patients treated and a first-ever base editing BLA planned for late 2026.

November 11, 2026

Pelacarsen Lp(a) HORIZON results infographic showing 78% Lp(a) reduction and hazard ratio 1.02

Pharmaceutical

Pelacarsen Lp(a) HORIZON Results: 78% Lp(a) Cut, No Heart Benefit

Novartis's pelacarsen lowered Lp(a) by 78% in 8,323 patients but did not reduce heart attacks, strokes or cardiovascular death in the Phase 3 Lp(a) HORIZON trial.

November 10, 2026

GLP-1 NAION warning infographic: FDA eye risk label change for Ozempic, Wegovy and Zepbound

Pharmaceutical

FDA Adds NAION Eye Warning to All GLP-1 Drugs, Including Ozempic, Wegovy and Zepbound

The FDA now requires every GLP-1 drug label, from Ozempic to Zepbound, to warn of a rare but serious eye condition called NAION. Here is what the data show and what patients should do.

November 10, 2026

India HealthTech funding in October 2026 for diagnostics, preventive care and kiosks

Healthcare IT

India Healthcare and Life-Sciences Startups Raised a Reported $173 Million Across 19 Rounds in October 2026

What India HealthTech funding in October 2026 pays for: AI diagnostics, preventive care and kiosks, and the gaps behind the headline total.

November 4, 2026

Hospital cybersecurity lessons from the reported EFS blood storage incident

Healthcare IT

French Blood Banks Hit by Reported Cyberattack on Cold-Storage Equipment, Authorities Investigate

Why hospital cybersecurity extends to refrigeration: the reported EFS blood storage incident, the safeguards that reportedly held and what is unconfirmed.

November 4, 2026

Medical Device

Smith+Nephew Says Talks With J&J Have Ended and Cuts 2026 Outlook as US Hip and Knee Sales Weaken

How the orthopaedic medical devices market looks from Smith+Nephew’s Q3: US knees down 7.3%, ex-US knees up 4.0%, and what the split suggests.

November 4, 2026

Vetter Expands Commercial Fill-and-Finish Capacity with Ten New Manufacturing Lines

Zolgensma Cancer Risk: FDA Confirms Gene Therapy Tumor Link in Two Children

Foundayo Sleep Apnea Trial: Lilly’s Pill Cuts AHI by Up to 44%

Tandem Mobi Recall: FDA Gives Class I Rating to False Occlusion Alarm Fix for 80,938 Insulin Pumps

Zolgensma Cancer Risk: FDA Confirms Gene Therapy Tumor Link in Two Children

Foundayo Sleep Apnea Trial: Lilly’s Pill Cuts AHI by Up to 44%

Tandem Mobi Recall: FDA Gives Class I Rating to False Occlusion Alarm Fix for 80,938 Insulin Pumps

Optune Mya FDA Not Approvable Letter: Why Novocure Missed on Brain Metastases

Risto-cel Sickle Cell Pivotal Data: Beam Base Editing Therapy Meets Primary Goal

Pelacarsen Lp(a) HORIZON Results: 78% Lp(a) Cut, No Heart Benefit

FDA Adds NAION Eye Warning to All GLP-1 Drugs, Including Ozempic, Wegovy and Zepbound

India Healthcare and Life-Sciences Startups Raised a Reported $173 Million Across 19 Rounds in October 2026

French Blood Banks Hit by Reported Cyberattack on Cold-Storage Equipment, Authorities Investigate

Smith+Nephew Says Talks With J&J Have Ended and Cuts 2026 Outlook as US Hip and Knee Sales Weaken

Vetter Expands Commercial Fill-and-Finish Capacity with Ten New Manufacturing Lines

Firefly Neuroscience and NeuroSigma Expand Access to Non-Drug Pediatric ADHD Treatment

InSilicoTrials Joins ARPA-H CIRCLE Program to Advance Digital Health Through Critical Care Digital Twins

Grünenthal and DKSH Expand Pain Medicine Partnership Across Eight Asia-Pacific Markets