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FDA & Regulation

19 analyses tagged FDA & Regulation
Biohacking

Cala kIQ Plus: The First Wearable Neurostimulator With Multiple Waveform Modes Goes National

The FDA-cleared Cala kIQ Plus is now available across the US: the first wearable with multiple stimulation waveform modes for action hand tremor.

Biohacking

Peptide Medicine's Gray Market Is Closing. Here's What Comes Next.

The gray-market peptide ecosystem — BPC-157, TB-500 — is formalizing under regulatory pressure. What that shift means for biohackers who depend on it.

Biohacking

FDA Puts Aging on Its Regulatory Science Agenda — What That Actually Means

The FDA added aging to its regulatory science agenda. It signals seriousness about longevity but creates no new trial pathway or approval. What it does mean.

Biohacking

Insilico Medicine's 287% Revenue Jump: AI Drug Discovery Is Becoming Real Pharma Revenue

Insilico Medicine grew to $106M revenue in H1 2026 on $7.3B in total deal value with Eli Lilly, Servier, and others — and a 90% gross margin that confirms AI drug pipelines have crossed from research promise to commercial scale.

Biohacking

Biological Age Clocks: The Regulatory Reckoning Is Coming

With $3.74 billion flowing into longevity biotech in Q1 2026 alone, investors are backing biological age diagnostics that regulators cannot yet validate. The collision between capital and clinical evidence is building.

Biohacking

5 Perimenopause Supplements That Hold Up: Evidence-Graded and Label-Checked

Most perimenopause supplement blends are underdosed and opaque. This evidence-graded breakdown applies clinical trial dosing standards to the current field — here are the five that survive scrutiny.

Biohacking

Blood Filtering Is the New Wellness Flex — And Viome Just Bought the Infrastructure

Viome's acquisition of Circulate Health pairs multi-omics biomarker testing with therapeutic plasma exchange. What this convergence means for longevity-focused consumers navigating an increasingly clinical wellness stack.

Biohacking

Timeline Wins $5.3M Judgment Against Fake Urolithin A Sellers

A federal court awarded Timeline $5.3M and permanent injunctions against 19 counterfeit urolithin A sellers — a case that signals the longevity supplement market is finally getting real enforcement.

Biohacking

Medtronic and Corsano Are Building the Hospital-to-Home Wearable Stack

Medtronic's integration of Corsano's FDA-cleared multi-parameter wearable into its HealthCast platform extends clinical monitoring from pre-op through home recovery — targeting alarm fatigue along the way.

Biohacking

Lung Cancer Screening for Never-Smokers: What the Data Says

Guidelines don't recommend lung cancer screening for never-smokers — but the evidence gap is a policy artifact, not a scientific finding. Peter Attia makes the case for personalized assessment.

Biohacking

Rapalogix: $20M to Bring Rapamycin Anti-Aging Science to Skincare

Rapalogix Health raised a $20M Series A to expand rapamycin-based skincare targeting TORC1 — the cellular pathway behind systemic longevity interventions, now applied topically.

Biohacking

Forever Chemicals Are Accelerating Your Biological Age — Longevity Needs to Catch Up

Two peer-reviewed studies link PFAS exposure to accelerated epigenetic aging via C-reactive protein. The longevity field's focus on what to add ignores what to remove — and that gap is measurable.

Biohacking

Battery-Free Brain Implant Leaves the Lab: ABILITY Neurotech's ALS Trial

ABILITY Neurotech's optical-link BCI received approval for chronic home use in ALS patients — the first time this class of device moves from controlled demonstrations to real-world daily use.

Biohacking

Wearables: When Your Fitness Tracker Becomes a Medical Device

WHOOP's 2025 FDA warning revealed a hidden boundary inside wearables. As brands add clinical features, the wellness exemption is under pressure — and the implications run far beyond WHOOP.

Biohacking

Wearables Are Writing Checks the FDA Can't Cash: The Regulatory Gap Getting Harder to Ignore

WHOOP earned $34.5M in federal backing. Apple Watch won an ECG clearance. And the FDA's framework for governing what these devices claim is still built for episodic care, not continuous monitoring.

Biohacking

Sunrise Air: What FDA Clearance for a Rechargeable Chin-Worn Sleep Test Actually Means

Sunrise Air's FDA clearance adds airflow sensors, O2 monitoring, and a rechargeable design to mandibular jaw tracking. What changes for home sleep diagnostics.

Biohacking

Diathrive + KardiaComplete: The Cardiometabolic Stack Getting FDA-Grade ECG Into Diabetes Care

People with Type 2 diabetes face 2-3x higher AFib risk, yet most digital health platforms treat heart and glucose monitoring separately. The Diathrive-KardiaComplete integration changes that.

Biohacking

Sky Labs CART: A Cuffless BP Ring With Real Regulatory Approval

Sky Labs' CART ring cleared UK MHRA and EU CE-MDR after 1,700 Korean hospitals and 150,000 prescriptions. What cuffless 24-hour BP monitoring actually requires.

Biohacking

Osteoboost's FDA-Cleared Wearable Uses Vibration to Slow Bone Loss

Osteoboost's prescription wearable delivers high-frequency vibration to the lumbar spine to slow bone density loss — FDA cleared, 82% adherence in trials, and backed by $8M to crack insurance coverage.

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