The Berke Report: Medical Device Update

Raises:

• Presidio Medical™ Announces $72M Equity Fundraising Led by Deerfield (PR)

• Tampa-based PainTEQ, a medical device company seeking to treat lower back pain, says it has closed on a new round of $35 million in financing from MVolution Partners LLC (businessobserverfl)

• Medtronic backs stealthy Foundry startup as it nabs $7.5M for novel remote patient monitoring (medtechdive)

• Append Medical Raises $4.35M in Initial Closing of Extended Series A Round (PR)

• Versant backs new, medtech-focused Vensana Capital fund, launching with $225M (fiercebiotech)

• Astek Diagnostics raises $2M for early warning UTI medical device (bioworld)

• Liberate Medical Secures $6.2M in Series B Financing. Series B Co-Led by a Large Strategic Investor and Scientific Health Development to Support the Pivotal Clinical Trial of the VentFree® Respiratory Muscle Stimulator (PR)

• Xtant Medical announces $15M private placement (massdevice)

• Vertos Medical Raises $26M for Minimally Invasive Spinal Procedure (medcitynews)

Approvals and Clinical:

• Surmodics Receives FDA Approval for the SurVeil™ Drug-Coated Balloon. Surmodics to receive $27 million milestone payment from Abbott (PR)

• FDA approves Biotronik’s Amvia Edge pacemaker portfolio (medicaldevicenetwork)

• FDA approves next-gen family of pacemakers from Biotronik (massdevice)

• Abbott scores FDA approval for world’s first leadless dual-chamber pacemaker (medicaldevicenetwork)

• FEops Receives FDA Clearance for Its AI-Based Anatomical Analysis Capabilities (PR)

• FDA approves Smith+Nephew’s AETOS Shoulder System (medicaldevicenetwork)

• USMI Receives FDA Approval for New Robotic Surgery Device – The Canady Flex RoboWrist™ (PR)

• Beta Bionics Announces FDA Clearance for the Use of a Prefilled Insulin Cartridge With the iLet Bionic Pancreas (PR)

M&A and Partnerships:

• Sensome and Asahi Intecc Forge Partnership to Develop Next-Generation Smart Guidewire and Transform Stroke Treatment (PR)

• GE HealthCare and DePuy Synthes are partnering in spine surgery (massdevice)

• Building a Vertically Integrated Diagnostics Powerhouse: EDP Biotech Corp. and New Day Diagnostics, LLC Announce Asset Merger (PR)

• ResMed acquires sleep and respiratory diagnostics software maker Somnoware (fiercebiotech)

• Johnson Matthey plans to sell medical device unit, Bloomberg reports (reuters)

• SunMed soaks up Avanos' respiratory health business for $110M (fiercebiotech)

• Merit Medical Announces Acquisition of Dialysis Catheter Portfolio and the BioSentry® Biopsy Tract Sealant System from AngioDynamics, Inc. and Acquisition of the Surfacer® Inside-Out® Access Catheter System from Bluegrass Vascular Technologies, Inc. (PR)

• Telix to Expand Late-Stage Urologic Pipeline with Acquisition of Lightpoint Medical (PR)

AI & ML:

• Medtronic and NVIDIA Collaborate to Build AI Platform for Medical Devices. Integrating NVIDIA Technology Into Medtronic’s Real-Time AI Endoscopy Device to Help Improve Patient Care and Outcomes (PR)

• FDA grants breakthrough designation for Anumana’s ECG-AI algorithm (medicaldevicenetwork)

• The importance of trust in AI as a medical device (healthcareitnews)

People Movement:

• Aethlon Medical Appoints Medical Device and Biomedical Executive, Nicolas Gikakis, to its Board of Directors (benzinga)

• MedHub-AI Appoints Medical Device Industrial Expert and Cardiac Care Innovator Dr. Justin Davies as President (PR)

• Former governor Matt Bevin now leading Louisville medical device company, report says (kentucky)

• Fresenius Medical Care names Martin Fischer as CFO (medtechdive)