FDA approves Philosys smartphone blood glucose monitor; Orthofix to restate earnings results;

@FierceMedDev: VC Rock Health partners with Abbott, expands digital health portfolio. Story | Follow @FierceMedDev

@StacyALawrence: Abbott gets $20M from DOD to develop portable concussion test. More | Follow @StacyALawrence

@VarunSaxena2: ICYMI: FDA targets off-label use of intranasal splint, with safety alert and Class I recall notice. Article | Follow @VarunSaxena2

@EmilyWFierce: Scientists at Biomeme developing a portable, real-time PCR machine that runs lab tests through a smartphone. Story via Wired | Follow @EmilyWFierce

> Philosys received FDA approval for its Gmate SMART Blood Glucose Monitoring System, a device and iPhone app combination designed to facilitate health management for diabetes patients. Release

> Orthofix announced several accounting errors relating to uncollectable patient copay and self-pay amounts. The company will restate finances going back to 2011 as a result. Story

> Atonarp raised $8M in a funding round to advance its Smart Spectrometer technology platform. The Series A round was led by Walden Riverwood Ventures. More

> GE Healthcare ($GE) announced the introduction of Vscan with Dual Probe, the first pocket-sized ultrasound tool to provide shallow and deep body images without changing probes. Read

Biotech News

@FierceBiotech: Sanofi wins FDA's blessing for an oral Gaucher drug. News | Follow @FierceBiotech

@JohnCFierce: Top trending story, 2 days now: Novo chief Sorensen preps for showdown as Lilly's dulaglutide nears diabetes market. Report | Follow @JohnCFierce

@DamianFierce: $FOLD CEO on positive new migalastat data, next-gen Fabry treatment and the importance of perseverance. Report | Follow @DamianFierce

@EmilyMFierce: Viral inducers plus antibodies thwart latent HIV in mice. FierceBiotech Research story | Follow @EmilyMFierce

> AstraZeneca's new antibiotic comes through in Phase III. Item

> Bristol-Myers, Celgene plan to match an immuno-oncology star with a rising chemotherapy. Story

> Could buying Salix get Valeant off of Allergan's scent? More

Pharma News

@FiercePharma: Top-read on FP Tues: Big Pharma doesn't win the margin stakes. That's Jazz, Celgene, Regeneron and Alexion. Report | Follow @FiercePharma

@TracyStaton: Been on vacay? @FiercePharma's top August news so far: Pfizer faces growing legal threat over Lipitor. More | Follow @TracyStaton

@EricPFierce: FDA warning letter for India's Marck Biosciences lays out in vivid detail why it banned its plant. Article | Follow @EricPFierce

@CarlyHFierce: Merck taps celeb chef to deliver diabetes message to Hispanics. Story | Follow @CarlyHFierce

> Depomed scores a win in its epic struggle to fend off Gralise copycats. Article

> Celgene's cost-sharing offer persuades NICE to about-face on Revlimid. Story

> Most of pharma's 2014 woes playing out as execs expected. More

Drug Delivery News

> Hydrogel enables longer graft survival in hand, leg transplant patients. Article

> Russian scientists close in on drug-delivering nanorobots. Story

> Study finds blood-brain barrier opening can be controlled, enabling enhanced drug delivery. More

> Mist formulation of Boehringer Ingelheim's COPD inhaler gets advisory committee nod. Story

> Scientists uncover new drug delivery method using nanosecond lasers and carbon nanotubes. Article

Diagnostics News

> Blood test for drug-resistant malaria strain shows promise. Report

> Two tests better than one to spot harmful mold infection. Story

> Cancer Genetics boosts Medicare coverage for DNA-based cancer Dx. More

> LabCorp jumps into prenatal Dx market already packed with rivals. Story

> Investors become ambivalent to Biocept's Dx commercialization plans. Article

Pharma Marketing News

> Celgene cost-sharing deal sways NICE to greenlight new Revlimid use. News

> When is 5 years not 5 years? When it's the FDA counting, Eisai claims. Report

> AbbVie aims to truck ahead with hep C testing promo campaign. More

> Hardest-charging drugs this year? They're not just Sovaldi and Olysio. Story

> Skeptical U.K. watchdogs decide to back Gilead's hep C star Sovaldi. Article

Suggested Articles

Akoya Biosciences raised $50 million to help boost its commercialization in research, drug development and clinical testing markets.

The dream of a comfortable, tabletop blood testing device, needing only a few drops taken from a finger and a handful of minutes, has now arrived.

Novartis is now teaming up with Amazon’s mammoth cloud computing division to overhaul its manufacturing, supply and business operations.