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

Finance Watch: Frazier Ups Its Public Fund To Place More Bets On SMID Caps
Public Company Edition: Frazier Life Sciences raised another $1.1bn for its Public Fund, bringing total capital commitments to $2.8bn. Also, two companies and a SPAC make IPO plans, Teva sells $4.9bn worth of notes, Intellia secures $400m in debt and Yarrows raises $150m.
Scrip - September 11, 2026

Disc Advances New Anti-Tmprss6 Agent DISC-3405 In Polycythemia Vera
The biotech unveiled positive data for what it called the first monoclonal antibody that targets Tmprss6, the same target as Silence’s siRNA divesiran.
Scrip - September 11, 2026

US FDA Finalizes Order Removing Two Filters From OTC Sunscreen Monograph
The US FDA determined that the risks of both PABA and trolamine salicylate outweigh their benefits as sunscreen active ingredients and removed them from the list of active ingredients permitted under the OTC sunscreen monograph.
HBW 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

Narasimhan Stands By Novartis M&A Record Despite Setbacks
The Switzerland-based giant’s CEO defends the purchase of Avidity after one of the deal’s major assets, del-desiran, failed in a study for myotonic dystrophy type 1.
Scrip - 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

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

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

Erasca Targets Lung Cancer In RAS Inhibitor Challenge To Revolution
The San Diego-based biotech is hot on the heels of its Californian neighbor, and believes its ERAS-0015 could show a safety and efficacy edge over Rasonque.
Scrip - 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

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

Executives On The Move: Vertex Expands Its Leadership Team Following Crinetics Acquisition
Among other executive moves are Inventiva appointing a chief operating officer ahead of a Phase III readout for lanifibranor in MASH, and Priothera adding a chief business officer to lead partnering for mocravimod as it advances through a Phase III trial in AML.
Scrip - September 11, 2026

China Grants Global-First Approval To Hengrui’s Oral TPO-RA In Thrombocytopenia
China approves Hengrui's hetrombopag as the world's first oral thrombopoietin receptor agonist for chemotherapy-induced thrombocytopenia in solid tumors.
Scrip - September 11, 2026

Don’t Miss the Call: Bad Contact Info Could Put Your Washington Lead Policy Status at Risk
Cosmetic manufacturers relying on Washington state's more flexible lead compliance options have a new reason to check their administrative housekeeping: a missed notice from Ecology could permanently close the door on their interim policy eligibility.
HBW Insight - September 11, 2026

Shionogi Considers Redasemtide’s Future After Mixed Phase II Readouts
Japanese company reviewing new mid-stage clinical findings for novel regeneration-inducing drug in dystrophic epidermolysis bullosa and acute ischemic stroke.
Scrip - September 11, 2026

Kyowa Kirin Encouraged By nAMD Eye Drop Results Despite Missed Endpoint
Japanese firm upbeat on other positive findings from study as it looks to progress non-invasive maintenance therapy for common eye disorder.
Scrip - September 11, 2026