Your first FDA clearance is just a fishing license.
Orthopedic startups chase FDA clearance like it’s the ultimate prize. Years of grinding through R&D, clinical trials, and regulatory hoops […]
FDA
The FDA 2.0
UPDATES Industry-Friendly FDA Leadership Regulatory Process Streamlining Increased Use of Real-World Evidence Potential Device Reclassification Political Influence on FDA Decisions
Potential changes for ortho companies at FDA under Trump.
With Trump victorious, biotech industry’s focus turns to his plans for FDA, FTC (MedTechDive)The president-elect has said he’ll let Robert
Goodbye stem cell clinics.
FDA just had a stupendous win in its battle against stem cell clinics The FDA claimed these clinics were plying
Zimmer’s CPT Hip System: Why Fracture Risks Are Forcing a Phase-Out.
Zimmer pulls hip implant off the market due to fracture risk (MedTechDive)The company plans to phase out use of its
Plain talk about the FDA’s real incentives.
Most people cannot say this out loud, but I will. When submitting a new device for approval, many ortho companies
FDA Slaps Globus Medical with Scathing Warning Over Spine Surgery Robot Failures
Globus receives warning letter over spine navigation robot (MedTechDive) Globus Medical received an FDA warning letter related to its ExcelsiusGPS
Startup treating knee cartilage defects is finishing out their Series A raise.
Early results for these knee cartilage defect patients are impressive in that the patients achieved early weight bearing. website –
Thoughts on the FDA and the Class III pathway.
Navigating the journey of a Class III regulatory approval in the US can be a daunting task for any ortho
5 regulatory pathways to get an orthopedic device cleared in the US
When developing a new orthopedic device or product, you need to consider the most appropriate FDA pathway to take. Most
Q&A update on a disruptive startup in hip fracture prevention.
CEO LEADERSHIP SERIES: HOW FLEXIBILITY AND TRANSPARENCY GOT THIS STARTUP THROUGH TOUGH TIMES (Ashton Tweed) Falling and breaking a hip
An FDA clearance ≠ “safe” for a NEW total shoulder system.
The following argument is made by Dr Frederick Matsen, Professor in the Department of Orthopaedics at the University of Washington;
A surgeon’s perspective of why orthopedics is not invested in improving the patient experience.
Reposting a thoughtful and objective article from Dr. William Kurtz to explain why healthcare has not invested in improving the
Is Orthopedic tech recession proof?
There is no question that we are in a recession now. We have all been reading about the consumer tech
The FDA is suffocating orthopedic innovation.
There has been a long PMA drought in orthopedics. This drought has been caused 100% by the FDA, not the
3Spine raises $33M for clinical trial for the 1st ever joint replacement for lumbar spine
website – https://3spine.com/ 3Spine raises US$33 million in Series C funding round (SpinalNewsInternational) 3Spine has raised US$33 million in an oversubscribed Series
Seeking CEO for orthopedic sensor startup with deferred compensation and equity.
This is a PSA for an orthopedic surgeon inventor friend. I have no financial interest… just trying to help a
Startup with wireless targeted electrical stimulation for spine fusion raises $5M
website – https://www.intelligentimplants.co/ Intelligent Implants scores €4.5 million blended financing from EIC Accelerator (press release) EIC funding will accelerate the
First PEEK femoral component in a primary TKA !
A PEEK bearing surface? Streamers… email me why this is a really good idea, or this a really bad idea.
The augmented reality surgical pioneer, Augmedics, raises $36M
“If you want to truly understand the future of orthopedic surgery, learn more about Augmedics.” –Tiger Read Q&A with Augmedics
FDA panel drills down on metal implants reactions
FDA panel wants info on metal implant reactions (TMGPulse) An FDA panel will meet this week to discuss immunological responses
Pssss… There is a “game-changer” biomaterial happening in spine.
The material is called ZFUZE. The secret: the team behind ZFUZE has cracked the code on the immune response. Translation: no inflammatory reaction =
FDA recall of Brainlab software used in spinal navigation
BRAINLAB ISSUES CLASS 1 RECALL OF ITS SPINAL NAVIGATION SOFTWARE (Orthopedics This Week) Definition: A Class I Recall is a situation in which
Intellirod Spine Receives First-Ever Spine FDA De Novo Approval
Intellirod Spine Receives First-Ever Spine FDA De Novo Approval (press release) MCRA Assists Intellirod Spine™ with 1st ever Spine De
The ROSA Robot system is cleared in the US for spine
Zimmer Biomet Receives FDA Clearance for Robotic ROSA One Spine System (press release) Zimmer Biomet becomes first company in the
Spine device to prevent spinal disc herniation wins PMA after setback
Device to prevent spinal disc herniation wins PMA after setback (MedTechDive) Barricaid Website – Intrinsic Therapeutics Dive Brief: Intrinsic Therapeutics has
Zimmer’s Rosa robot, acquired in 2016, is cleared for Total Knee surgeries in the US
Zimmer Biomet Receives FDA Clearance for ROSA® Knee System for Robotically-Assisted Surgeries (press release) Zimmer Biomet Holdings, Inc. (NYSE and SIX:
Is Cervical Disc Arthroplasty still “experimental” ?
CERVICAL DISC ARTHROPLASTY NOT “EXPERIMENTAL.” WELL, YEAH. (Orthopedics This Week) Why is the most studied spinal implant in history considered to be “experimental”?
FDA clears absorbable foot and ankle pins
FDA clears absorbable foot and ankle implant (MedTechDive) Ossio website Dive Brief: Ossio announced Monday it received FDA 510(k) clearance for a