Product categories

Biologics

Proteins, antibodies, vaccines and plasma products, licensed through a BLA or an EU marketing authorisation.

18 stories

Biosimilars

Follow-on biologics approved on comparability to a reference product rather than on a full dossier.

2 stories on this site

• CHMP Clears First mAb Biosimilar Under New EU Path
• FDA Drafts Rules for Biosimilar Autoinjectors, Syringes

Inhalation & Nasal Drug Products

Inhalers, nebulised products and nasal sprays, where device and drug are reviewed together.

1 story on this site

• MHRA Approves the World's First Low-Carbon Asthma Inhaler

Injectable Therapies

Parenteral products and the autoinjectors, pens and prefilled syringes that deliver them.

5 stories on this site

• CHMP Recommends Zealand's Zeydovio for Bowel Disease
• EMA Reviews Injectable Iron Drugs Over Bone-Risk Reports
• FDA Clears LEROCHOL Autoinjector, Adds CV Risk Claim
• FDA Drafts Rules for Biosimilar Autoinjectors, Syringes
• FDA Approves MannKind's 10-Second Heart-Failure Autoinjector

Oral Solid Dosage Forms

Tablets and capsules, and the bioequivalence and dissolution questions that follow them.

5 stories on this site

• FDA Issues 55 New Bioequivalence Guidances for Generics
• FDA Revises Guidance on ANDA vs. 505(b)(2) Filings
• FDA Grants Hearing on Generic Concerta After Decade
• FDA Finalizes Adhesion Rules for Generic Skin Patches
• FDA Retires a 1995 Guidance on Topical Steroids

Small Molecule Drugs

Chemically synthesised medicines, reviewed through the NDA, ANDA and 505(b)(2) routes.

10 stories on this site

• Cogent's Bezuclastinib Notches Third Simultaneous NDA
• FDA Approves Telix's Pixclara for Glioma Imaging
• FDA Issues 55 New Bioequivalence Guidances for Generics
• FDA Finalizes Guidance on Generic Drug TE Codes
• FDA Revises Guidance on ANDA vs. 505(b)(2) Filings
• FDA's GDUFA IV Plan Would Raise Foreign Drug Fees
• FDA Grants Hearing on Generic Concerta After Decade
• UK First in Europe to Approve Lilly's Foundayo Pill
• and 2 more, in the archive

Topical & Transdermal Products

Creams, gels and patches, where delivery through skin is the review question.

4 stories on this site

• Beta Bionics Wins FDA Clearance for Mint Patch Pump
• FDA Grants Nutromics' Patch Breakthrough Status
• FDA Finalizes Adhesion Rules for Generic Skin Patches
• FDA Retires a 1995 Guidance on Topical Steroids

Vaccines

Prophylactic and therapeutic vaccines, their strain changes and their advisory committees.

3 stories on this site

• FDA Approves Fall 2026 COVID Shots, Keeps Narrow Use
• FDA Approves First mRNA Flu Vaccine, Moderna's mFLUSIVA
• CHMP Backs the EU's First Refillable Eye Implant

Drug Delivery Systems

Pumps, infusion sets and delivery devices regulated with the product they administer.

4 stories on this site

• TriSalus Wins FDA Clearance for TriNav Advance
• Beta Bionics Wins FDA Clearance for Mint Patch Pump
• FDA Finalizes Adhesion Rules for Generic Skin Patches
• CHMP Backs the EU's First Refillable Eye Implant

Imaging Systems

CT, MRI, ultrasound and radiographic systems, and the software read alongside them.

4 stories on this site

• Koning Health Wins TGA Approval for Breast CT System
• FDA Approves Telix's Pixclara for Glioma Imaging
• FDA Posts First Two Warning Letters Under New QMSR
• FDA Lets Proscia Add Scanners Without New 510(k)s

Implantable Devices

Devices placed in the body — valves, leads, stimulators, orthopaedic implants.

10 stories on this site

• HighLife Raises $90M for US Valve Trial, EU Growth
• FDA Approves Cordis' Sirolimus-Eluting Balloon
• Dialybrid Raises €15M, Implants First Vascular Graft
• Shoulder Innovations Clears FDA Hurdle for N-22 Implant
• Emboline Clears FDA Hurdle for TAVR Debris Filter
• MHRA Flags Wear Risk in Five Modular-Neck Hip Implants
• Boston Scientific Cyberattack Halts Device Shipments
• FDA Clears Sight Sciences' OMNI Ultra for Glaucoma
• and 2 more, in the archive

Patient Monitoring Systems

Bedside and ambulatory monitors, and the alarms and signals regulators inspect.

4 stories on this site

• Powerful Medical Wins First FDA Nod for AI-ECG Tool
• FDA Clears Tempus's AI Tool for Pulmonary Hypertension
• MHRA Flags Ventilator Failure Risk in Dräger Atlan Units
• FDA Classifies Ventilator, Heart-Pump Recalls as Class I

Robotics

Robotic surgical and interventional systems, and the human-factors case behind them.

5 stories on this site

• FDA Clears Neptune Medical's Robotic Endoscope
• FDA Clears First Robotic LigaSure Vessel Sealer
• FDA Breakthrough Status for Remote Robotic Stroke Device
• FDA Clears Spineart's Robotic Spine Screw App
• FDA Authorizes First Robotic Blood-Draw Device

Sterile & Single-Use Devices

Single-use instruments and sterile barriers, where sterilisation and reprocessing decide the file.

No coverage yet — we track it, and will report it when it moves.

Surgical Systems

Operating-theatre systems — energy devices, staplers, navigation and the instruments around them.

6 stories on this site

• TriSalus Wins FDA Clearance for TriNav Advance
• FDA Clears First Robotic LigaSure Vessel Sealer
• FDA Breakthrough Status for Remote Robotic Stroke Device
• MHRA Flags Wear Risk in Five Modular-Neck Hip Implants
• FDA Clears Spineart's Robotic Spine Screw App
• MHRA Warns Against Infant Gas-Relief Catheters

Wearables

Body-worn sensors and therapeutics, from continuous monitors to wearable rings and patches.

3 stories on this site

• FemPulse Earns CE Mark for Wearable Bladder Ring
• FDA Grants Nutromics' Patch Breakthrough Status
• FDA Clears Abbott's Libre Duo Glucose-Ketone Monitor

Artificial Intelligence (AI/ML)

Machine-learning devices, predetermined change control plans and the generative-AI question.

6 stories on this site

• FDA Denies Bid to Exempt Radiology AI From 510(k)
• Beta Bionics Wins FDA Clearance for Mint Patch Pump
• FDA Names Permanent CDER, CBER Chiefs, New AI Post
• FDA Clears Tempus's AI Tool for Pulmonary Hypertension
• FDA Weighs a Competency Test for AI Medical Devices
• FDA Lets Proscia Add Scanners Without New 510(k)s

Clinical Decision Support (CDS)

Software that informs a clinician’s judgement, and where the line of enforcement discretion falls.

No coverage yet — we track it, and will report it when it moves.

Connected Medical Devices

Networked devices, their interoperability and the post-market surveillance the connection creates.

No coverage yet — we track it, and will report it when it moves.

Cybersecurity

Premarket cyber documentation, SBOMs and the vulnerability disclosures that follow a device to market.

1 story on this site

• Boston Scientific Cyberattack Halts Device Shipments

Digital Therapeutics (DTx)

Software that treats a condition, cleared on clinical evidence rather than on claims.

1 story on this site

• FDA Approves First Gene Therapy for GSDIa

Mobile Medical Applications

Apps that are devices, and the guidance that decides which of them are.

No coverage yet — we track it, and will report it when it moves.

Remote Patient Monitoring (RPM)

Monitoring outside the clinic, and the reimbursement and safety questions it raises.

No coverage yet — we track it, and will report it when it moves.

Software as a Medical Device (SaMD)

Software that is itself the device, classified on the seriousness of the decision it drives.

1 story on this site

• FDA Denies Bid to Exempt Radiology AI From 510(k)

Cell Therapy

Cell-based products, from CAR-T to stem-cell therapies, and their RMAT and CAT routes.

1 story on this site

• FDA's Cell Therapy Panel Revisits a Once-Rejected DMD Drug

Gene Therapy

Vectors and gene editing, their long-term follow-up and their accelerated approvals.

4 stories on this site

• Cyllene Wins FDA RMAT Status for Bladder Gene Therapy
• FDA Approves First Gene Therapy for Sanfilippo Type A
• FDA Finalizes FAQ Guide for Cell, Gene Therapies
• FDA Approves First Gene Therapy for GSDIa

Regenerative Medicine

Products that restore function, and the RMAT designation written for them.

1 story on this site

• Cyllene Wins FDA RMAT Status for Bladder Gene Therapy

Tissue-Engineered Products

Engineered tissue and scaffolds, reviewed where biologic and device rules meet.

No coverage yet — we track it, and will report it when it moves.

Companion Diagnostics

Tests that select a therapy, approved alongside the drug they are tied to.

2 stories on this site

• FDA Approves Lilly's Inluriyo-Verzenio Combo
• FDA Eases Path for Cancer Companion Diagnostics

In Vitro Diagnostics (IVD)

Laboratory tests under the IVDR and the US framework, including laboratory-developed tests.

5 stories on this site

• UpFront Diagnostics Earns CE Mark for Stroke Test
• FDA Clarifies Path for Spectral's Sepsis Device
• Brussels Says Only Manufacturers May Assign a Device's UDI
• FDA Retires a 1995 Guidance on Topical Steroids
• EUDAMED's Next Deadline Is Narrower Than It Looks

Molecular Diagnostics

Nucleic-acid and sequencing-based tests, and the evidence their claims rest on.

No coverage yet — we track it, and will report it when it moves.

Point-of-Care Diagnostics

Tests run where the patient is, including over-the-counter and CLIA-waived formats.

No coverage yet — we track it, and will report it when it moves.

3D Printing

Additive manufacturing of devices, including point-of-care production.

No coverage yet — we track it, and will report it when it moves.

Biomaterials

Materials in contact with the body, and the biocompatibility evidence they need.

No coverage yet — we track it, and will report it when it moves.

Combination Products

Drug-device and biologic-device combinations, and which centre leads the review.

1 story on this site

• FDA Drafts New Guidance on Drug Container Closures

Nanotechnology

Nanomaterials and nanoscale delivery, where characterisation carries the file.

No coverage yet — we track it, and will report it when it moves.