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Orthopedics

Locate Bio lands FDA breakthrough nod for bone infection device

January 7, 2021 By Nancy Crotti

Regenerative medicine company Locate Bio announced today that the FDA has granted breakthrough device designation to a bone graft/antibiotic combination designed to combat chronic bone infection, also known as osteomyelitis. Osteomyelitis is a progressive, inflammatory infection of the bone, usually caused by bacteria and is estimated to account for up to 50% of all non-trauma […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Orthopedics, Pharmaceuticals, Regenerative Medicine Tagged With: FDA, Locate Bio

OsteoRemedies wins FDA nod for Remedy Spectrum GV hip spacer and bone cement

November 1, 2018 By Danielle Kirsh

OsteoRemedies-logo

OsteoRemedies recently announced that it has received FDA clearance for its Remedy Spectrum GV hip spacer system and Spectrum GV bone cement. The system is designed to give surgeons a broad spectrum of treatment options with both Gentamicin and Vancomycin. “We are very proud to have the first FDA cleared dual-antibiotic spacer system and bone […]

Filed Under: Orthopedics Tagged With: OsteoRemedies

Flexion reports data from Phase II bilateral osteoarthritis trial

October 22, 2018 By Sarah Faulkner

Flexion Therapeutics - updated logo

Flexion Therapeutics (NSDQ:FLXN) touted data today from a Phase II trial assessing the bilateral dosing of its extended-release triamcinolone acetonide injection in people with bilateral osteoarthritis. The study found that bilateral injections of Flexion’s Zilretta therapy resulted in lower plasma concentrations of triamcinolone acetonide compared to immediate-release triamcinolone acetonide in crystalline suspension (TAcs). The company also […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Orthopedics, Wall Street Beat Tagged With: Flexion Therapeutics

Genentech wins FDA nod for subcutaneous formulation of arthritis drug

September 14, 2018 By Sarah Faulkner

Genentech logo updated

Roche‘s (OTC:RHHBY) Genentech reported this week that the FDA approved the subcutaneous formulation of tocilizumab for the treatment of active systemic juvenile idiopathic arthritis in patients two years and older. The U.S. agency approved the intravenous formulation of Actemra for the same indication in 2011. Systemic juvenile idiopathic arthritis affects roughly 30,000 children in the U.S., according […]

Filed Under: Featured, Food & Drug Administration (FDA), Orthopedics, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Genentech

Medtech stories we missed this week: August 3, 2018

August 3, 2018 By Danielle Kirsh

missed-medtech-0803

From Esaote launching its new ultrasound device to Nipro’s Infraredx launching in Japan, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Esaote launches new ultrasound devices Esaote announced in an Aug. 2 press release that it has launched its new MyLab X7, MyLab X6 and MyLab X5 ultrasound systems. […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Hospital Care, Imaging, Implants, Orthopedics, Patient Monitoring, Regulatory/Compliance Tagged With: Bonesupport, Esaote, Infraredx, ivwatch, medtech, Mindshare Medical, Modulated Imaging, MTF Biologics, Nipro

Anika tops sales, EPS estimates with Q2 results

July 25, 2018 By Sarah Faulkner

Anika Therapeutics

Anika Therapeutics (NSDQ:ANIK) reported its second-quarter financial results today, topping sales and earnings estimates on Wall Street. The Bedford, Mass.-based company posted profits of $10 million, or 69¢ per share, on sales of $30.5 million for the 3 months ended June 30, for bottom-line loss of -11% on sales loss of -9% compared with the same […]

Filed Under: Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Orthopedics, Pharmaceuticals, Wall Street Beat Tagged With: Anika Therapeutics Inc.

Medtech stories we missed this week: July 13, 2018

July 13, 2018 By Danielle Kirsh

missed-medtech-0713

From Angiodroid receiving CE Mark approval to Masimo launching its vital signs app, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Angiodroid wins CE Mark for Angiopulse IABP Angiodroid announced in a July 11 press releasethat it has received CE Mark approval for its AngioPulse intra-aortic balloon pump […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Hospital Care, Imaging, Optical/Ophthalmic, Orthopedics, Patient Monitoring, Regulatory/Compliance, Surgical

Anika swings to a loss in Q1

May 3, 2018 By Sarah Faulkner

Anika Therapeutics

Shares in Anika Therapeutics (NSDQ:ANIK) fell in premarket activity today after the company missed expectations on Wall Street with its first-quarter results. The Bedford, Mass.-based company swung to a net loss of -$6.7 million, or -46¢ per share, on sales of $21.3 million for the 3 months ended March 31, down -9.1% compared with the same […]

Filed Under: Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Orthopedics, Pharmaceuticals, Wall Street Beat Tagged With: Anika Therapeutics Inc.

Medtech stories we missed this week: April 27, 2018

April 27, 2018 By Danielle Kirsh

canyon at sunset

From DuPuy Synthes’s spinal implant launch to Lumendi’s FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. DePuy Synthes launches spinal implants DePuy Synthes announced in an April 26 press release that it has launched its Proti 360º integrated titanium family of interbody devices that are designed to […]

Filed Under: Featured, Food & Drug Administration (FDA), Hematology, Hospital Care, Orthopedics, Regulatory/Compliance Tagged With: abbott, apolloendosurgery, Cerus Corp., DePuy Synthes, lumendi, PAVmed, reshapelifesciences, sanquin

Flexion touts interim data from Ph3 trial of osteoarthritis injection

April 27, 2018 By Sarah Faulkner

Flexion Therapeutics (NSDQ:FLXN) this week touted updated, interim results from an ongoing Phase IIIb study evaluating the safety and tolerability of repeat administration of its osteoarthritis injection, Zilretta. The company’s injectable suspension is an extended-release formulation of triamcinolone acetonide designed for patients with osteoarthritis of the knee. Top-line results from Flexion’s trial showed that 95% of […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Orthopedics, Pharmaceuticals, Wall Street Beat Tagged With: Flexion Therapeutics

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