Medical Devices
Page 1 • 12 itemsGain critical insights into global medical device regulatory pathways, market trends, and innovation impacting pharmaceutical R&D and commercialization.
CVRx Enrolls First Patient in BENEFIT-HF Heart Failure Trial Testing Barostim Device
CVRx begins landmark BENEFIT-HF clinical trial for Barostim neuromodulation device in expanded heart failure patient population at Avera Heart Hospital.
Smartee Denti-Technology Advances Mandibular Repositioning Technology at European Aligner Society Congress 2026
Smartee Denti-Technology presents breakthrough mandibular repositioning innovations and European expansion strategy at EAS Congress 2026 in Brussels.
Cerus Corporation INTERCEPT Blood System Advances Through European Regulatory Review and Phase 3 Trials
Cerus Corporation's INTERCEPT Blood System progresses through European regulatory review while Phase 3 RedeS trial readout and new INT200 device submission planned.
FDA Real-World Evidence Framework Shifts $10B Toward Validated Medtech Platforms Like VentriPoint
FDA's new real-world evidence requirements for medical devices create $10B market shift favoring established platforms with proven performance data.
SQ Innovation's Lasix ONYU Receives CE Marking Approval, Advances Toward European Market Authorization
SQ Innovation announces CE marking for Lasix ONYU medical device under EU MDR, plus EMA centralized procedure eligibility for European market expansion.
Advanced Bifurcation Systems Acquires Svelte Medical Systems in Major Coronary Stent Deal
Advanced Bifurcation Systems Inc. acquires Svelte Medical Systems, expanding its coronary angioplasty portfolio with drug-eluting stents and regulatory approvals.
Boston Scientific Corporation Faces Securities Class Action Lawsuit with May 4 Deadline for Investors
Boston Scientific investors have until May 4, 2026 to join securities class action lawsuit. Rosen Law Firm encourages shareholders to secure legal counsel.
Femasys Launches FemaSeed Complete Fertility Solution for OB/GYNs at ACOG 2026
Femasys Inc. launches FemaSeed Complete at ACOG 2026, enabling OB/GYNs to perform first-line fertility insemination in their practices for 10M infertile women.
Mauna Kea Technologies Secures CE Mark Under New MDR, Expands European Medical Device Approvals
Mauna Kea Technologies obtains CE Mark under new Medical Device Regulation and regulatory approvals in UK and Switzerland, marking significant expansion.
Boston Scientific Reports Strong Q1 2026 Growth with 10.9% US Sales Increase and Clinical Trial Breakthroughs
Boston Scientific delivers robust Q1 2026 performance with double-digit growth across all regions and presents breakthrough clinical trial data at major conference.
Getinge Receives CE Mark for Cardiohelp II ECLS System and EU MDR Approval for Intergard Synergy Vascular Graft
Getinge AB achieves major regulatory milestones with CE mark for Cardiohelp II ECLS system and EU MDR approval for Intergard Synergy antimicrobial vascular graft.
Implantica RefluxStop Device Shows Excellent Long-Term Safety in Landmark 602-Patient European Study
Implantica's RefluxStop acid reflux device demonstrates excellent long-term safety in largest real-world study of 602 patients across 22 European centers.