MedGadget: Medical Device, Pharma & Healthcare News

Timeline graphic: SAB-142 FDA Fast Track designation, showing the SAFEGUARD and PRISE-hATG trial windows after type 1 diabetes diagnosis and topline data due in 2027

FDA Grants Fast Track Status to SAB-142, an Experimental Immunotherapy for Type 1 Diabetes

SAB-142 FDA Fast Track designation covers new-onset Stage 3 type 1 diabetes. Phase 2b data are due in 2H 2027; the drug is not approved.

October 14, 2026

Graphic: Sensydia cardiac monitoring funding, a heart signal trace beside notes on investigational use only status and the ACOUSTIC-1 study

Medical Device

Sensydia Raises Over $6 Million to Advance Noninvasive Cardiac Monitoring Device Toward FDA Review

Sensydia cardiac monitoring funding: over $6M led by Colle Capital to take its noninvasive CPS through ACOUSTIC-1. It is not yet FDA authorised.

October 14, 2026

Graphic: computer vision syndrome India, an eye facing a screen with the 20-20-20 rule for reducing digital eye strain

Healthcare Services

AIIMS Bhubaneswar Raises Concern Over Computer Vision Syndrome Among Young People

Computer vision syndrome India: AIIMS Bhubaneswar warns young people face more refractive errors and screen strain. Symptoms and eye-care steps.

October 14, 2026

Graphic: CORUS PCSS 3D-T FDA clearance, an illustrative porous titanium lattice pattern beside notes on posterior cervical fusion and no reported 3D-T clinical data

Medical Device

FDA Clears Providence Medical Technology 3D-Printed Titanium Implant for Cervical Spine Fusion

CORUS PCSS 3D-T FDA clearance adds a porous titanium lattice to a cervical fusion system. No clinical data for the new version have been reported.

October 14, 2026

Graphic: Butterfly Medical prostate device EU approval, an enlarged prostate with an implant opening the urethra beside notes on a 244-patient trial and a pending FDA application

Medical Device

Butterfly Medical Secures EU Certification for Enlarged Prostate Treatment Device

Butterfly Medical prostate device EU approval: the BPH implant gains EU MDR certification. A 244-patient trial is complete; no US approval yet.

October 14, 2026

Calendar graphic: Merck ESMO 2026 Phase 3 results, five congress days from 23 to 27 October with the melanoma and endometrial cancer presentations highlighted

Pharmaceutical

Merck Announces Phase 3 Melanoma and Endometrial Cancer Data for ESMO 2026

Merck ESMO 2026 Phase 3 results: intismeran in melanoma and sac-TMT in endometrial cancer will be shown in full on 23-27 October. Neither is approved.

October 14, 2026

Graphic: CINAINU FDA Breakthrough Therapy, a scalp with hair strands and a bare patch beside a panel noting ages 2 and older and a Phase 2/3 trial in 107 children

Pharmaceutical

FDA Grants Breakthrough Therapy Designation to CINAINU for Alopecia Areata

CINAINU FDA Breakthrough Therapy status covers alopecia areata from age 2. It is not approval, and the company has released no efficacy figures.

October 14, 2026

Graphic: Johnson & Johnson Q3 2026 results, $25.4B in sales with a tall arrow for Innovative Medicine up 7.7% and a short arrow for MedTech up 2.5%

Pharmaceutical

Johnson & Johnson Q3 2026 Revenue Reaches $25.4 Billion as Medical Device Growth Slows

Johnson & Johnson Q3 2026 results: sales of $25.4B, up 5.9%; medicines +7.7%, MedTech +2.5%. Guidance raised, but GAAP profit fell sharply.

October 13, 2026

Graphic: Roche Rona Therapeutics obesity deal, a fat cell with ALK7 receptors and an siRNA strand beside $100M near-term and $1.06B milestone tags

Pharmaceutical

Roche Licenses Rona Therapeutics’ ALK7 RNAi Obesity Drug in Deal Worth Up to $1.16 Billion

Roche Rona Therapeutics obesity deal is worth up to $1.16 billion for an ALK7 RNAi candidate. Only $100M is near term, and benefit is unproven.

October 13, 2026

Graphic: AK0406 FDA Phase 2 trial, an antibody Fc shape carrying antiviral molecules beside a timeline from Phase 1 in Australia to FDA IND clearance

Pharmaceutical

FDA Clears Phase 2 Trial of AK0406, a Long-Acting Influenza Prevention Drug

AK0406 FDA Phase 2 trial cleared: ArkBio will test its long-acting flu prevention candidate in a placebo-controlled study. No human efficacy data yet.

October 13, 2026

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

Bristol Myers Squibb Q3 2026 Results: What the Pipeline Data on CELMoDs and Admilparant Show

Laurus Labs Galenvs Acquisition: The Oligonucleotide and Nanoparticle Technology Behind the Deal

Fortis Healthcare Acquisition of Suguna Hospital: What Consolidation Means for Care Quality in Bengaluru

FDA Grants Fast Track Status to SAB-142, an Experimental Immunotherapy for Type 1 Diabetes

Sensydia Raises Over $6 Million to Advance Noninvasive Cardiac Monitoring Device Toward FDA Review

AIIMS Bhubaneswar Raises Concern Over Computer Vision Syndrome Among Young People

FDA Clears Providence Medical Technology 3D-Printed Titanium Implant for Cervical Spine Fusion

Butterfly Medical Secures EU Certification for Enlarged Prostate Treatment Device

Merck Announces Phase 3 Melanoma and Endometrial Cancer Data for ESMO 2026

FDA Grants Breakthrough Therapy Designation to CINAINU for Alopecia Areata

Johnson & Johnson Q3 2026 Revenue Reaches $25.4 Billion as Medical Device Growth Slows

Roche Licenses Rona Therapeutics’ ALK7 RNAi Obesity Drug in Deal Worth Up to $1.16 Billion

FDA Clears Phase 2 Trial of AK0406, a Long-Acting Influenza Prevention Drug

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