Rakuten Fortifies Global Expertise With Ex-Takeda CEO Weber
Rakuten Medical expects experienced new board members will help it reach regulatory and commercial milestones in the US market.
Scrip - September 14, 2026

Quick Listen: Scrip’s Five Must-Know Things
This week: what’s next in cardiovascular R&D following Phase III failures; gains for nine of world’s top 10 drugs in Q2; AstraZeneca’s COPD contender out-performs Dupixent in Phase III; Renexxion co-founder on naronapride in gastroparesis; and Chinese companies' global Phase III activity.
Scrip - September 14, 2026

Flow Neuroscience Launches At-Home, FDA-Approved Brain Stimulation Device For Depression In US
Flow Neuroscience launched its FDA-approved at-home tDCS device FL-100 in the US this week at a patient cost of $2,200 for an initial 10-week course and $325 for every additional four weeks of treatment.
Medtech Insight - September 11, 2026

CDRH Moves To Close Rare Disease Device Gap With New Initiative And Device List
CDRH’s Rare Disease Impact Initiative seeks to advance the development and authorization of devices to treat rare diseases. The effort aims to address development challenges, identify unmet device needs, strengthen collaboration, and provide resources including a Rare Disease Medical Device List.
Medtech Insight - September 11, 2026

German Industry Assesses Reimbursement And Health Reform Challenges As Bundestag Resumes
The German health system is broaching self-pay for certain diagnostics in certain settings. On one hand, it widens access, but on the other, patients’ inability or reluctance to pay might become a stumbling block.
Medtech Insight - September 11, 2026

FDA Approval In Hand, Implantica Prepares To Launch Mechanical GERD Fix In US
Implantica is launching RefluxStop in the US after a PMA approval that was based entirely on European trial data. A Medicare pass-through decision is expected in six to 12 months.
Medtech Insight - September 11, 2026

Bridge To Life’s $110m Bet On Making Hypothermic Perfusion —And Viability Testing— Standard Of Care
Bridge to Life closed a $110m Series C to fund a US commercial push for VitaSmart, its cold HOPE perfusion system, betting a simpler, cheaper workflow undercuts NMP rivals — with an FMN viability diagnostic, still in validation, as the intended moat.
Medtech Insight - September 11, 2026

Plaque Plus Physiology: Elucid’s $55m Series D Funds A Two-Front Coronary AI Push
Elucid has closed a $55m Series D to back a two-product platform strategy in coronary CT analysis — one tool measuring plaque already cleared, one measuring blood flow still under FDA review.
Medtech Insight - September 11, 2026

Diagnostics Firms Expect German Health Minister To Deliver On Market Access And ‘Dialog’ Agenda
Martin Walger sees change ahead for the German diagnostics industry, whose interests he has represented as head of the VDGH industry association since 2009. In a series of interviews, he describes an industry coping with financial realities, the EU IVDR, and first, adjusting to a new health minister
Medtech Insight - September 11, 2026

Xlear Complaint Making Loper Bright Argument In Challenge To FTC Health Claim Policy Dismissed
With Xlear not contesting an active enforcement, “the case is not ripe for judicial review,” meaning the district “court lacks subject matter jurisdiction over the claims … and dismisses this action without prejudice,” Utah District Court ruling states.
HBW Insight - September 14, 2026

Henlius Sees Overseas Profits Quadruple In H1 As Collaborations Expand
As the Chinese biopharma company continues through the year it shows no signs of slowing down, reporting revenue growth of more than a quarter and a leap in profits from overseas as it expands its industry partnerships.
Generics Bulletin - September 11, 2026

Regulatory Recap: Indonesia Reinstates Anti-Evergreening Provision In Patent Law
Generics Bulletin reviews global regulatory developments across the world.
Generics Bulletin - September 11, 2026

Sandoz’s Spravato Generic Blocked From US Market Until 2035
Sandoz cannot launch its proposed generic Spravato nasal spray before September 2035 after losing a five-day patent trial, while earlier settlements removed Alkem and Hikma from the litigation.
Generics Bulletin - September 11, 2026

Graveyard Drug Hunters: How Racura And Cereno Are Repurposing Drugs That Pharma Threw Away
A contrarian cohort of drug companies is betting that pharma's most undervalued assets are the ones it already threw away.
In Vivo - September 14, 2026